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 May 5)
- AbbVie Inc. (NYSE:ABBV)
- Globus Medical, Inc. (NYSE:GMED)
- GT Biopharma, Inc. (NASDAQ:GTBP)
- Penumbra, Inc. (NYSE:PEN)
- PRA Health Sciences, Inc. (NASDAQ:PRAH)
- Quest Diagnostics Incorporated (NYSE:DGX)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows May 5)
Stocks In Focus
Stealth Biotherapeutics Reports Positive Phase 1 Data For Eamipretide In Retinal Disorder
Stealth BioTherapeutics Corp (NASDAQ:MITO) presented at the Association for Research in Vision and Ophthalmology meeting with positive data from a post hoc analysis of the Phase 1 ReCLAIM study evaluating elamipretide in patients with non-central geographic atrophy and high risk drusen associated with dry age-related macular degeneration.
The data showed that for patients with GA treated with elamipretide for 24-weeks, the improvements from baseline in low light visual acuity, which is the primary efficacy endpoint, were significantly correlated to baseline assessments of mitochondrial health in the ellipsoid zone.
"Based on the data presented showing an association between outer retinal features and treatment response to elamipretide, this approach to imaging biomarker interrogation may provide a unique opportunity for clinical trial enrichment and identification of eyes that are more likely to benefit from treatment," said Dr. Justis Ehlers, a clinical ophthalmologist.
The stock jumped 16.67% to $1.40 in after-hours trading.
Sanofi To Work With Stanford School Of Medicine On Immunology, Inflammation Research
Sanofi (NASDAQ:SNY) said it has entered into a three-year research collaboration with the Stanford University School of Medicine, with the collaboration focusing on the advancement of the understanding of immunology and inflammation through open scientific exchange.
Additionally, Sanofi will provide funding and scientific inputs into projects of mutual interest, crossing multiple therapeutic areas including autoimmune diseases and inflammatory conditions.
The two entities will create a Joint Steering Committee to fund up to three programs a year.
Quidel's Over-The-Counter COVID-19 Test Kits To Be Distributed Through Walgreens Stores
Moderna Announces Positive Phase 2 Data For Booster Dose of COVID-19 Vaccines, Mixed Q1
Separately, the company announced a new supply agreement with the Swiss government for 7 million doses of booster vaccine in 2022, with an additional option for another 7 million doses for delivery during the second half of 2022 or first quarter of 2023.
Moderna also reported first-quarter results, showing below-consensus revenues but better-than-expected EPS.
The stock was down 1.68% to $160.10 in premarket trading Thursday.
Related Link: Week Ahead In Biotech (May 2-8): ChemoCentryx Adcom, Ophthalmology Conference Presentations, Earnings Deluge
Merck Keytruda Combo Treatment Gets FDA Nod For First-Line Stomach Cancer Treatment
Merck, Inc. (NYSE:MRK) said the FDA has approved Keytruda, its anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherap, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Merck shares were down 0.57% at $77.26 in premarket trading Thursday.
Earnings
G1 Therapeutics, Inc. (NASDAQ:GTHX) reported revenues of $14.2 million for the first quarter and its net loss per share narrowed from 82 cents to 65 cents. Analysts, on average, estimated a loss of $1.07 per share.
The stock rallied 6.47% to $21.05 in after-hours trading.
10x Genomics, Inc.'s (NASDAQ:TXG) first-quarter revenues climbed 47% year-over-year to $105.8 million. The net loss per share narrowed from 22 cents to 11 cents. The results were ahead of the estimates.
The company maintained its full-year revenue guidance of $480 million to $500 million.
The stock shed 9.79% to $165 in after-hours trading.
OraSure Technologies, Inc. (NASDAQ:OSUR) reported 85% revenue growth and above-consensus EPS for the first quarter.
The stock added 5.1% to $9.48 in after-hours trading.
On The Radar
Adcom Calendar
Clinical Readouts
Palatin Technologies, Inc. (NYSE:PTN) will present at the ARVO meeting with data from the Phase 2 study of PL9643 in dry eye disease (11:15 a.m. to 1 p.m.)
Applied Genetic Technologies Corporation (NASDAQ:AGTC) is scheduled to present at the ARVO meeting with 12-month findings from two Phase 1/2 clinical studies of subretinal gene therapy drugs for achromatopsia.
Earnings
Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates
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