The Daily Biotech Pulse: Allogene Sinks On FDA Clinical Hold, Takeda Gets Adcom Backing, Quidel Reports Q3 COVID Revenues, IPOs
Here’s a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Oct. 7)
- Alkermes plc ALKS
- Bicycle Therapeutics plc BCYC (announced interim Phase 1 data for BT5528 and preliminary results from Phase 1 study of BT8009)
- Catalyst Pharmaceuticals, Inc. CPRX
- Cytokinetics, Incorporated CYTK
- Enanta Pharmaceuticals, Inc. ENTA
- Legend Biotech Corporation LEGN
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Oct. 7)
- Acutus Medical, Inc. AFIB
- Adverum Biotechnologies, Inc. ADVM
- Akoya Biosciences, Inc. AKYA
- Amgen Inc. AMGN ( announced neurodegenerative disease drug collaboration with Nuemora)
- Angion Biomedica Corp. ANGN
- Applied DNA Sciences, Inc. APDN
- Applied Molecular Transport Inc. AMTI
- ARCA biopharma, Inc. ABIO
- Avenue Therapeutics, Inc. ATXI
- Aytu Biopharma, Inc. AYTU
- Aziyo Biologics, Inc. AZYO
- BiondVax Pharmaceuticals Ltd. BVXV
- BioSig Technologies, Inc. BSGM
- BioVie Inc. BIVI
- Black Diamond Therapeutics, Inc. BDTX
- Calliditas Therapeutics AB (publ) (NASDAQ: acquired full control of Genkyotex)
- Cellectis S.A. CLLS
- Chemomab Therapeutics Ltd. CMMB
- China SXT Pharmaceuticals, Inc. SXTC
- Clarus Therapeutics Holdings, Inc. CRXT
- Concert Pharmaceuticals, Inc. CNCE
- CureVac N.V. CVAC
- Cytosorbents Corporation (CTSO)
- DICE Therapeutics, Inc. DICE
- Eiger BioPharmaceuticals, Inc. EIGR
- Esperion Therapeutics, Inc. ESPR
- First Wave BioPharma, Inc. FWBI
- Forma Therapeutics Holdings, Inc. FMTX (announced presentation of Phase 1 data for prostate cancer drug)
- Gain Therapeutics, Inc. GANX
- Galapagos NV GLPG
- Galecto, Inc. GLTO
- Graphite Bio, Inc. GRPH
- Harpoon Therapeutics, Inc. HARP
- Histogen Inc. HSTO
- HOOKIPA Pharma Inc. HOOK
- IMARA Inc. IMRA
- InMed Pharmaceuticals Inc. INM
- Inozyme Pharma, Inc. INZY
- Kala Pharmaceuticals, Inc. KALA
- Kaleido Biosciences, Inc. KLDO
- Kiromic BioPharma, Inc. (NASDAQ: KRBP
- Liminal BioSciences Inc. LMNL
- Lipocine Inc. LPCN
- Lixte Biotechnology Holdings, Inc. LIXT
- Longeveron Inc. LGVN
- Mesoblast Limited MESO
- Minerva Neurosciences, Inc. NERV
- Moleculin Biotech, Inc. MBRX
- MorphoSys AG MOR
- Nautilus Biotechnology, Inc. NAUT
- Neovasc Inc. NVCN
- NeuroBo Pharmaceuticals, Inc. NRBO
- NRx Pharmaceuticals, Inc. NRXP
- Nuwellis, Inc. NUWE
- Onconova Therapeutics, Inc. ONTX
- Oncorus, Inc. ONCR
- ORIC Pharmaceuticals, Inc. ORIC (presented initial clinical data from Phase 1b study of ORIC-101 in combination with enzalutamide, in metastatic prostate cancer patients)
- Oyster Point Pharma, Inc. OYST
- Orphazyme A/S ORPH
- Osmotica Pharmaceuticals plc OSMT (announced securing of $100 million in debt financing)
- Pasithea Therapeutics Corp. KTTA
- Petros Pharmaceuticals, Inc. PTPI
- Pluristem Therapeutics Inc. PSTI
- Plus Therapeutics, Inc. PSTV
- POINT Biopharma Global Inc. PNT
- Prelude Therapeutics Incorporated PRLD
- Pulmatrix, Inc. PULM
- Relay Therapeutics, Inc. RLAY
- Repare Therapeutics Inc. RPTX
- Repro Med Systems, Inc. KRMD
- Roivant Sciences Ltd. ROIV (listed Oct. 1 following a SPAC deal)
- Sangamo Therapeutics, Inc. SGMO
- Silverback Therapeutics, Inc. SBTX
- Solid Biosciences Inc. SLDB
- Spectrum Pharmaceuticals, Inc. SPPI
- Spruce Biosciences, Inc. SPRB
- Stoke Therapeutics, Inc. STOK
- Surrozen, Inc. SRZN
- Takeda Pharmaceutical Company Limited TAK
- TCR2 Therapeutics Inc. TCRR
- Teligent, Inc. TLGT
- Titan Pharmaceuticals, Inc. TTNP
- Turning Point Therapeutics, Inc. TPTX
- Unity Biotechnology, Inc. UBX
- Viveve Medical, Inc. VIVE
- XBiotech Inc. XBIT
- Xeris Pharmaceuticals, Inc.
Stocks In Focus
Quidel Pre-announces Strong Q3 Profits Development as COVID-19 Incomes Continue to Be Salubrious
Quidel Corporation QDEL said it anticipates total third-quarter incomes to be in the variety of $505 million-$ 510 million, up 6-7% year-over-year. The company noted that it delivered over 45 million SARS tests, 135% higher than a year-ago. COVID-19 earnings are anticipated to be roughly $406 million, compared to $375.7 million in the year-ago duration.
The stock was adding 6.45% to $145 in premarket trading.
Allogene Automobile T Cell Treatment Trials Put On Hold By FDA On Report Of Chromosomal Irregularity In a Patient
Allogene Rehabs, Inc. ALLO stated following a report of a chromosomal abnormality in ALLO-501A VEHICLE T cells in a patient dealt with in the ALPHA2 study, the U.S. Food and Drug Administration has placed a hang on its AlloCAR T medical trials.
The company said it expects to offer additional updates in the coming weeks following consultation with the FDA. The FDA continues to actively evaluate completion of Stage 1 materials sent in anticipation for an ALLO-501A essential Phase 2 trial.
The stock was dropping 36.55% to $15.47 in premarket trading.
Codiak Sciences Says Sarepta Prematurely Cancels 2-Year License and Alternative Contract For Usage Of Exosomes In Non-viral Gene Delivery
Codiak BioSciences, Inc. CDAK said Sarepta Rehab, Inc. SRPT had alerted it Oct. 1 that it was ending early the two-year research license and option agreement, reliable June 17, 2020, in between the business. The termination will be efficient since Dec. 3.
The arrangement focused on making use of exosomes for non-viral shipment of AAV, gene-editing and RNA rehabs to attend to five concurred targets related to neuromuscular illness.
As an outcome of the termination, each of the license and alternative approved to Sarepta shall terminate in its whole, according to the terms of the agreement, and the business shall gain back all rights previously granted to Sarepta.
Chemocentryx Announces FDA Nod For Drug to Treat Autoimmune Illness That Causes Destruction of Little Blood Vessels
ChemoCentryx, Inc., CCXI revealed FDA approval of Tavneos (avacopan), as an adjunctive treatment of adult patients with serious active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, in combination with basic treatment. ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system more activates neutrophils, causing inflammation and eventual destruction of little capillary.
The stock was pulling away 6.17% to $18.39 in premarket trading.
BeiGene’s Brukinsa Gets Australian Regulatory Nod For Treating Slow-growing Lymphoma
BeiGene, Ltd. BGNE announced that Brukinsa has been authorized in Australia for the treatment of adult clients with Waldenström’s macroglobulinemia who have received at least one prior therapy or in first line treatment for clients unsuitable for chemo-immunotherapy.
Mirati, Sanofi Collaborate to Study Combo Treatment For Lung Cancer Patients With KRAS Anomaly
Mirati Rehabs, Inc. MRTX revealed a non-exclusive scientific partnership arrangement with Sanofi SNY to examine the combination of adagrasib, its KRASG12C inhibitor, with Sanofi’s investigational SHP2 inhibitor SAR442720, likewise called RMC-4630.
The Phase 1/2 dose escalation and expansion study will assess the mix in clients with previously-treated non-small cell lung cancer and KRASG12C mutations.
Under the regards to the agreement, Sanofi will be accountable for operating the phase and sponsoring 1/2 study, and jointly with Mirati, will oversee and share costs of the study.
Takeda’s Cytomegalovirus Treatment Gets Unanimous Backing Of FDA Panel
Takeda revealed FDA’s Antimicrobial Drugs Advisory Committee voted all to suggest usage of maribavir for the treatment of refractory cytomegalovirus infection and illness with or without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant receivers.
The stock was up 1.25% to $14.55 in premarket trading.
Nkarta Offers Updates On Its Early-stage NK Cell Treatment Candidates
In a scientific trial upgrade, Nkarta, Inc. NKTX stated it has actually begun the medical trial assessing NKX019 in CD19+ innovative B cell malignancies. The company anticipates initial data from the study in 2022. In addition, the company anticipates to launch initial information from the Stage 1 research study of NKX101 in intense myeloid leukemia and myelodysplastic syndrome in the first half of 2022.
Stealth Presents Favorable Results From Animal Study of Its AML Prospect
At the 2021 Yearly Northeast Amyotrophic Lateral Sclerosis meeting Stealth BioTherapeutics Corp MITO provided new promising data from a study evaluating the impacts of SBT-272 in a murine model of amyotrophic lateral sclerosis.
Systemic administration of SBT-272 in rodents resulted in sustained SBT-272 levels across various regions of the brain and protected mitochondria versus ischemic tension, verifying that the compound crosses the blood brain barrier and has mitoprotective effects, the business stated.
In premarket trading, the stock was rising 2.16% to $1.42.
Intellia Falls On Expert Sales
Intellia Therapies, Inc. NTLA shares came under pressure after the company revealed in a filing Crowley John, a director of the business, sold all 10,000 shares he acquired the working out of options.
The stock was down 2.885 at $130.90 in premarket trading.
Humanigen’s COVID-19 Treatment Prospect to Be Provided In 16 European Nations Under A Managed Gain Access To Program
Humanigen, Inc. HGEN stated it has actually gotten in into a plan with Clinigen Group, a global pharmaceutical product and services company, to implement a managed gain access to program for lenzilumab, named LenzMAP.
LenzMAP, which is to be offered in 16 European nations, will make it possible for access to lenzilumab on a case-by-case basis for hospitalized patients with COVID-19 where the dealing with physician considers there to be no ideal options and where policies allow.
The stock was up 5.19% at $6.69 in premarket trading.
Agile Rehabs, Inc. AGRX announced that it intends to use and offer shares of its common stock and warrants to acquire shares of its common stock in an underwritten public offering.
The stock was plunging 23% at 73.50 cents in premarket trading.
Cidara Therapies, Inc. CDTX announced that it has actually commenced concurrent however separate underwritten public offerings of its common stock and its Series X convertible favored stock.
In premarket trading, the stock was receding 12.83% to $1.63.
Discussions at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapies
Mersana Therapies, Inc. MRSN presented new preclinical information for its antibody-drug conjugate XMT-2056, which targets an unique epitope of human skin development aspect receptor 2.
” New head-to-head preclinical information comparing XMT-2056 to TLR7/8-agonist ADC and systemically-administered STING agonist criteria even more supports the potential benefits of XMT-2056 to use greater effectiveness and a broader healing index,” the business said.
eFFECTOR Rehabs EFTR, in cooperation with detectives at Baylor College of Medication, provided new favorable data for zotatifin in animal designs of triple-negative breast cancer.
eFFECTOR stock was rallying 28.48% to $14.75 in premarket trading.
Relay Therapies: initial outcomes of RLY-4008 in clients with FGFR2-altered cholangiocarcinoma and numerous strong tumors (10:25 am).
Repare Therapeutics: Information from the Phase I TRESR trial of RP-3500 in clients with innovative solid tumors harboring synthetic lethal genomic changes (3:15 pm).
The company clarified in a release late Thursday that there was an unintended early issuance of an abstract highlighting the upcoming oral discussion, which included outcomes taken from a very early cutoff date. The presentation due Friday will consist of both considerably more patient information in addition to a later cut-off date and ensuing longer follow up.
IsoPlexis Corporation ISO priced its initial public offering of 8.333 million shares at $15 each compared to the estimated rate variety of $14-$ 16. The shares will start trading on the Nasdaq under the ticker sign “ISO.”.
The business’s single cell proteomics platform has actually been embraced by the leading international biopharmaceutical business and detailed cancer centers in the U.S. to help establish more resilient rehabs, get rid of therapeutic resistance, and anticipate client reactions for innovative immunotherapies, cell therapies, gene treatments, vaccines, and regenerative medicines.
Pyxis Oncology, Inc., PYXS, a portfolio company of equity capital fund Arix Bioscience plc, priced its IPO of 10.5 million shares of common stock at $16 per share for aggregate gross profits of $167.2 million. Pyxis’ typical stock is expected to begin trading on the Nasdaq under the ticker symbol “PYXS.”.
The company noted that it delivered over 45 million SARS tests, 135% higher than a year-ago. CDAK stated Sarepta Therapeutics, Inc. SRPT had notified it Oct. 1 that it was terminating early the two-year research license and option agreement, effective June 17, 2020, between the companies. The company expects initial information from the study in 2022. Furthermore, the business anticipates to release initial data from the Stage 1 study of NKX101 in acute myeloid leukemia and myelodysplastic syndrome in the first half of 2022.