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Here's a roundup of top developments in the biotech space over the last 24 hours:
(Biotech Stocks Hitting 52-week Highs May 10)
(Biotech Stocks Hitting 52-week Lows May 10)
BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) announced the Food and Drug Administration has expanded the emergency use authorization for the companies' COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.
In after-hours trading, BioNTech shares added 9.68% to $201.49 and Pfizer shares were up 0.33% to $39.99.
Ascendis Pharma A/S (NASDAQ:ASND) announced preliminary 58-week results from a continuing open-label extension portion of a Phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH in adult subjects with hypoparathyroidism, showing after one year of treatment, the investigational product candidate was well-tolerated at all doses and provided durable benefit in adults with HP.
Data from these subjects provided evidence suggesting they are establishing physiologic calcium metabolism based upon normalization of 24-hour urine calcium excretion and a downward trend toward mid-normal levels in bone markers without the use of therapeutic calcium and vitamin D supplementation.
Kodiak Sciences Inc. (NASDAQ:KOD) shares extended a post-earnings slide seen Monday, with traders reacting to a potential regulatory filing delay.
The company is evaluating KSI-301 for four retinal disorder indications. With the company adding another pivotal study, the initial biologic license application filing will be delayed from the earlier communicated timeline of 2022 to the first quarter of 2023.
The stock slipped 14.39% to $87 in after-hours trading.
Cerecor Inc. (NASDAQ:CERC) said the FDA has granted fast track designation to CERC-002 for treatment of hospitalized patients with COVID-19.
The stock was up 13.39% to $2.88 in premarket trading Tuesday.
Related Link: The Week Ahead In Biotech (May 9-15): Heron, Apellis FDA Decisions, Presentations and Earnings
Eli Lilly and Company (NYSE:LLY) and MiNA Therapeutics Limited announced a global research collaboration to develop novel drug candidates using MiNA's proprietary small activating RNA technology platform.
Under the terms of the agreement, MiNA will utilize its saRNA platform to research up to five targets selected by Lilly that aim to address diseases across Lilly's key therapeutic focus areas, and Lilly will be responsible for preclinical and clinical development and commercialization.
Lilly will pay MiNA a $25-million upfront payment and potential development and commercialization milestones up to a total of $245 million per target, as well as tiered royalties from the low single to low double digits on product sales resulting from the collaboration.
Prothena Corporation plc (NASDAQ:PRTA) announced that it has earned a $60-million milestone payment from its worldwide collaboration with Roche Holding AG (OTC:RHHBY), based on the first patient dosed in the Phase 2b PADOVA study of prasinezumab in patients with early Parkinson's disease.
In after-hours trading, the stock was up 6.88% to $25.
ChemoCentryx, Inc. (NASDAQ:CCXI) shares, which suffered a bloodbath last week on an adverse Adcom ruling, are finding some support after a filing revealed that Tausif Butt, its COO, bought 10,870 shares at $11.0617 per share.
The stock gained 8.13% to $11.31 in after-hours trading.
AlloVir, Inc. (NASDAQ:ALVR) shares came under pressure after a filing revealed its chief scientific officer Ann Leen sold 150,000 shares in the company at $22.75 per share.
InspireMD, Inc. (NYSE:NPSR) said its shares have been approved for listing on the Nasdaq. Trading is expected to begin on May 21 under the symbol "NSPR" on the Nasdaq.
The stock was down 6.12% to $4.45 in premarket trading Tuesday.
Geron said its first-quarter net loss per share widened from 8 cents in 2020 to 9 cents in 2021. The company reaffirmed its operating expense burn guidance for 2021.
The stock was up 9.6% to $1.37 in after-hours trading.
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a sharp decline in first-quarter revenues from $1.3 million to $371,000. The loss per share of 27 cents was wider than the 18-cent per share loss estimated by analysts.
The stock was losing 7.05% to $6.20 in premarket trading Tuesday.
Novavax, Inc.'s (NASDAQ:NVAX) first-quarter revenues increased from $3.38 million in 2020 to $447.3 million in 2021. The loss per share widened from 58 cents to $3.05. The company said it intends to file for emergency use authorization for its COVID-19 vaccine candidate with regulators in the U.S., Europe and U.K. in the third quarter.
In after-hours trading, the stock fell 12.77% to $1.40.
Larimar Therapeutics, Inc. (NASDAQ:LRMR) is scheduled to release topline data from placebo-controlled, Phase 1 program evaluating CTI-1601 in Friedreich's ataxia patients.
AVROBIO, Inc. (NASDAQ:AVRO): Updated results from a Phase 1/2 clinical trial evaluating hematopoietic stem cell lentiviral gene therapy AVR-RD-04 for cystinosis
Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT): Interim results from a Phase 1/2 Study of lentiviral-mediated ex-vivo gene therapy for pediatric patients with severe leukocyte adhesion deficiency-I
Flexion Therapeutics, Inc. (NASDAQ:FLXN): Preliminary data from a Phase 1 single ascending dose trial of FX201, an intra-articular gene therapy candidate, for osteoarthritis
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE): Updated results from a Phase 1/2 study of AAV8 gene therapy as a potential treatment in adults with late-onset ornithine transcarbamylase deficiency
Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates
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