Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
AbbVie's Rinvoq Gets Label Expansion To Treat Ulcerative Colitis
AbbVie, Inc. (NYSE:ABBV) announced the Food and Drug Administration has approved its Rinvoq for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. This FDA approval is the first indication for Rinvoq in gastroenterology.
AstraZeneca's Antibody Cocktail Gets UK Regulatory Nod For Preventing COVID-19; UK Biopharma Announces $775M Settlement Agreement
AstraZeneca plc's (NASDAQ:AZN) antibody cocktail Evusheld was authorized for preventing COVID-19 by the U.K. drug regulator, the Medicines And Healthcare Products Regulatory Agency. Evusheld is a combination of two long-acting antibodies that works by binding to the spike protein on the outside of the SARS-CoV-2 virus, the virus that causes COVID-19. This in turn prevents the virus from attaching to and entering human cells.
Separately, AstraZeneca and its Alexion unit said they hvae entered into a settlement agreement with Chugai Pharmaceuticals Co. Ltd. (OTC:CHGCY) to resolving all patent disputes between the two companies related to Ultomiris.
Under the terms of the agreement, Alexion will make a single payment of $775 million in the second quarter of 2022. The settlement does not impact AstraZeneca's financial guidance for 2022.
AstraZeneca shares were down 0.79% at $61.47 in premarket trading.
Stealth BioTherapeutics Announces Positive Preclinical Data For DMD Treatment Candidate
Stealth BioTherapeutics Corp. (NASDAQ:MITO) presented at the 2022 Muscular Dystrophy Association and Clinical and Scientific Conference with new data demonstrating the potential synergistic relationship between elamipretide and an exon skipping phosphorodiamidate morpholino oligomer in the X-linked muscular dystrophy mouse model.
"These data demonstrating the promise of combined elamipretide and PMO therapies offer early support for this premise, energizing our efforts to develop improved therapeutic options for DMD patients," said Reenie MacCarthy, CEO of Stealth.
The stock was adding 11.13% to $63.90 in premarket trading.
Clover Reports Positive Data For COVID-19 Vaccine Candidate As Booster Dose Against Omicron Variant
Chinese biopharma Clover is developing a COVID-19 vaccine candidate named SCB-2019 that uses Dynavax Technologies Corporation's (NASDAQ:DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide. Clover reported positive results from several studies evaluating the investigational vaccine. The company noted that 100% efficacy was maintained against severe COVID-19 and 95% efficacy against hospitalization at five months after the second dose.
A booster dose of SCB-2019 also produced significant neutralizing antibodies against the omicron variant in both homologous and heterologous settings.
BridgeBio Shares Gain On Insider Buying
BridgeBio Pharma, Inc. (NASDAQ:BBIO) disclosed in a filing that Douglas Dachille, a director of the company's board, acquired 10,000 shares in the company.
The stock was adding 3.85% to $9.70 in premarket trading.
Click here to access Benzinga's FDA calendar.
On The Radar
Clinical Readouts/Presentations
Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR) will host a conference call at 8:30 a.m. EDT to discuss the results from the Phase 3 TOGETHER study of Peginterferon Lambda for COVID-19.
Karyopharm Therapeutics, Inc. (NASDAQ:KPTI) will present at the Society of Gynecologic Oncology Annual Meeting on Women's Cancer, Phase 3 data for oral selinexor/placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer.
Earnings
- Liquidia Corporation (NASDAQ:LQDA) (before the market open)
- Synlogic, Inc. (NASDAQ:SYBX) (before the market open)
- Acutus Medical, Inc. (NASDAQ:AFIB) (before the market open)
- MediWound Ltd. (NASDAQ:MDWD) (before the market open
- X4 Pharmaceuticals, Inc. (NASDAQ:XFOR) (before the market open)
- Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (before the market open)
- CymaBay Therapeutics, Inc. (NASDAQ:CBAY) (after the close)
- Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) (after the close)
- Avadel Pharmaceuticals plc (NASDAQ:AVDL) (after the close)
- Onconova Therapeutics, Inc. (NASDAQ:ONTX) (after the close)
- Trevi Therapeutics, Inc. (NASDAQ:TRVI) (after the close)
Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates
