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 Nov. 10)
- Amicus Therapeutics, Inc. FOLD
- Celldex Therapeutics, Inc. CLDX
- Denali Therapeutics Inc DNLI (announced biomarker proof-of-concept was achieved for its Transport Vehicle technology in a Phase 1/2 study of DNL310 for the potential treatment of Hunter syndrome)
- Fate Therapeutics Inc FATE
- Harmony Biosciences Holdings Inc HRMY
- Kura Oncology Inc KURA
- Kymera Therapeutics Inc KYMR
- MannKind Corporation MNKD
- Ocular Therapeutix Inc OCUL
- OncoSec Medical Inc ONCS
- Pacific Biosciences of California Inc PACB
- Retrophin Inc RTRX
- Shockwave Medical Inc SWAV
- Spero Therapeutics Inc SPRO
- Stoke Therapeutics Inc STOK
- Vericel Corp VCEL
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Nov. 10
- Aziyo Biologics Inc AZYO
- Baudax Bio Inc BXRX
- Eyegate Pharmaceuticals Inc EYEG
- Galmed Pharmaceuticals Ltd GLMD
- Global Blood Therapeutics Inc GBT
- Nabriva Therapeutics PLC – ADR NBRV
- PainReform Ltd PRFX
- Polypid Ltd PYPD
- Qualigen Therapeutics Inc QLGN
- Repro-Med Systems, Inc. KRMD
Stocks In Focus
Five Prime Therapeutics' Antibody Treatment Candidate Aces Mid-stage Study In Gastric Cancer
Five Prime Therapeutics Inc FPRX announced positive topline results from its Phase 2 study that compared mFOLFOX6 chemotherapy in combination with bemartiuzumab in patients with fibroblast growth factor receptor 2b-positive, non HER2 positive front-line advanced gastric or gastroesophageal junction cancer.
The company noted that all three efficacy endpoints met pre-specified statistical significance, with median progression-free survival improving from 7.4 months to 9.5 months and median overall survival increasing and overall response rate improving by 13.1%,
Five Prime is developing the investigational therapy with Zai Lab Ltd – ADR ZLAB in Greater China and has granted exclusive license to the latter in the region.
Five Prime shares skyrocketed 364.42% to $24.80 in after-hours trading.
Eisai, Merck Report Positive Results For Combo Treatment In Advanced Kidney Cancer Patients
Eisai Co., Ltd ESALY and Merck & Co., Inc. MRK announced new investigational data demonstrating positive top-line results from the pivotal Phase 3 CLEAR trial evaluating Lenvima, Eisai's orally available multiple receptor tyrosine kinase inhibitor, plus Keytruda as well as Lenvima plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma.
Inventiva Reports Positive Outcome for End-of-Phase 2 Meeting With FDA For NASH Drug
Following an end-of-Phase 2 meeting with the FDA, Inventiva ADR Representing Ord Shs IVA said the FDA indicated that Inventiva's clinical strategy to conduct a single pivotal Phase 3 trial may be sufficient to support the filing of a NDA for its lead drug candidate lanifibranor in NASH. The FDA also confirmed that Inventiva may request accelerated approval for lanifibranor in the event of a positive benefit-risk ratio determination based on an interim histology analysis to be conducted during the Phase 3 trial. The initiation of the Phase 3 trial is planned for the first half of 2021, the company added.
Pfizer/BioNTech Strike Deal to Supply Up to 300M Doses of Coronavirus Vaccine To EU
Pfizer Inc. PFE and BioNTech SE – ADR BNTX announced an agreement with the European Commission to supply 200 million doses of their < a href="https://www.benzinga.com/analyst-ratings/analyst-color/20/11/18299631/pfizer-analysts-raise-odds-of-success-for-coronavirus-vaccine-candidate-to-100">investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to European Union Member States, with an option for the European Commission to request an additional 100 million doses.
Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization, the companies said.
Separately, Pfizer announced positive top-line results from the Phase 3 JADE REGIMEN study that investigated abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in patients 12 and older with moderate to severe atopic dermatitis following response to initial open label induction treatment with abrocitinib 200mg.
Co-Diagnostics' Platform Found Effective In Saliva-based PCR Tests Without Requiring RNA Sample Extraction
Co-Diagnostics Inc CODX said its recebt whitepaper demonstrates that the CoPrimer platform technology can be used to identify the presence of SARS-CoV-2 in human saliva samples without first requiring RNA extraction of the sample, and can do so while providing low limits of detection.
The stock was advancing 8.84% to $12.80 in premarket trading Wednesday.
Miragen Therapeutics Inc MGEN said its third-quarter net loss narrowed from 36 cents in 2019 to 10 cents in 2020. The loss was narrower than the 13-cent per share loss estimated by analysts.
In after-hours trading, the stock was down 10.88% to 96 cents.
Viela Bio Inc VIE reported net product sales of $2.3 million for the third quarter, comprising solely of Uplinza sales, compared to no revenues in the year-ago period.
Uplinza was approved by the FDA in mid-June for the treatment of neuromyelitis optica spectrum disorder in adult patients with a particular antibody.
The net loss per share narrowed from $64.59 per share to 69 cents per share, while analysts had estimated a wider loss of 76 cents per share.
The stock slipped 13.86% to $31.87 in after-hours trading.
Clearpoint Neuro Inc's CLPT third-quarter revenues increased 20% year-over-year to $3.5 million. The net loss per share widened from 8 cents to 9 cents. Analysts had estimated a loss of 14 cents per share.
In after-hours trading, the stock gained 12.85% to $7.73.
Esperion Therapeutics Inc ESPR said it intends to offer, subject to market conditions and other factors, $200 million aggregate principal amount of convertible senior subordinated notes due 2025 in a private offering to qualified institutional buyers.
The stock fell 6.57% to $27 in after-hours trading.
PacBio said it has priced its previously announced underwritten public offering of an aggregate of 7.40 million shares of its common stock at $14.25 per share, for raising gross proceeds of $86.9 million.
Organogenesis Holdings Inc ORGO announced that it is offering 17.5 million shares of its Class A common stock in an underwritten public offering.
The stock was down 8.76% to $3.96 in after-hours trading.
Keros Therapeutics Inc KROS said it has filed a registration statement on Form S-1 with the SEC relating to a proposed underwritten public offering of 2.25 million shares of its common stock.
ORIC Pharmaceuticals Inc ORIC said it has commenced an underwritten public offering of 4 million shares of its common stock. All of the shares in the proposed offering will be sold by the company.
On The Radar
Applied Genetic Technologies Corp AGTC is due to release 12-month data for Groups 1 through 4 evaluating durability of effect, and continued safety and interim data of Groups 5 and 6 evaluating safety and efficacy at higher doses for its Phase 1/2 clinical trial of AGTC-501 in patients with X-linked retinitis pigmentosa.
The Society for Immunotherapy of Cancer Annual Meeting Presentations
Replimune Group Inc REPL will announce in a poster presentation updated data from the skin cancer cohort of the Phase 1/2 clinical trial of RP1, combined with Bristol-Myers Squibb Co's BMY Opdivo.
Nektar Therapeutics NKTR will make an oral presentation of 2-1/2 year data for metastatic melanoma patients treated with bempegaldesleukin plus Opdivo, and promising early data for NKTR-255 as well as NKTR-262.
Agenus Inc AGEN is scheduled to present additional clinical responses with its Fc-enhanced anti-CTLA-4, AGEN1181.
Curis, Inc. CRIS will present a poster on the Phase 1 Study of CI-8993 anti-VISTA antibody in patients with advanced solid tumor malignancies.
Spring Bank Pharmaceuticals Inc SBPH will make a poster presentation that will include an update on the progress of the IV SB 11285 alone and in combination with Roche Holdings AG's RHHBY in a Phase 1a/1b trial in patients with advanced solid tumor.
American Academy of Ophthalmology Virtual Meeting Presentations
Aldeyra Therapeutics Inc ALDX is due to release new clinical utility data from the Phase 2 allergen chamber clinical trial of reproxalap in allergic conjunctivitis.
Polypid Ltd PYPD (before the market open)
Ascendis Pharma A/S ASND (after the close)
TELA Bio Inc TELA (after the close)
Cyclacel Pharmaceuticals Inc CYCC (after the close)
Trevi Therapeutics Inc TRVI (after the close)
OpGen Inc OPGN (after the close)
Salarius Pharmaceuticals Inc SLRX (after the close)
PDL BioPharma Inc PDLI (after the close)
Outset Medical Inc OM (after the close)
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