The Daily Biotech Pulse: Merck's Keytruda Snags Another FDA Approval, Moderna Slips On Revenue Miss, Chemocentryx Adcom

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. ABBV
• Globus Medical, Inc. GMED
• GT Biopharma, Inc. GTBP
• Penumbra, Inc. PEN
• PRA Health Sciences, Inc. PRAH
• Quest Diagnostics Incorporated DGX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 5)

• ACADIA Pharmaceuticals Inc. ACAD
• Acutus Medical, Inc. AFIB
• Adverum Biotechnologies Inc ADVM
• Agile Therapeutics, Inc. AGRX (reacted to first-quarter results)
• Akouos, Inc. AKUS
• Aptinyx Inc. APTX
• Atea Pharmaceuticals, Inc. AVIR
• Atreca, Inc. BCEL
• Autolus Therapeutics plc AUTL
• AVROBIO, Inc. AVRO
• Axcella Health Inc. AXLA
• Aytu Biopharma, Inc. AYTU
• Baudax Bio, Inc. BXRX (announced first-quarter results)
• Bellerophon Therapeutics, Inc. BLPH
• BioXcel Therapeutics, Inc. BTAI
• Celyad Oncology SA CYAD
• Concert Pharmaceuticals, Inc. CNCE
• Decibel Therapeutics, Inc. DBTX
• Deciphera Pharmaceuticals, Inc. DCPH
• Dyadic International, Inc. DYAI
• Emergent BioSolutions Inc. EBS
• Evofem Biosciences, Inc. EVFM
• Finch Therapeutics Group, Inc. FNCH
• Gain Therapeutics, Inc. GANX
• Galecto, Inc. GLTO
• Haemonetics Corporation HAE
• Ionis Pharmaceuticals, Inc. IONS (reacted to first-quarter results)
• Kala Pharmaceuticals, Inc. KALA (announced first-quarter results)
• Karyopharm Therapeutics Inc. KPTI
• Longboard Pharmaceuticals, Inc. LBPH
• Lyra Therapeutics, Inc. LYRA
• Metacrine, Inc. MTCR
• MorphoSys AG MOR
• NeuroBo Pharmaceuticals, Inc. NRBO
• NextCure, Inc. NXTC
• NuCana plc NCNA
• Olema Pharmaceuticals, Inc. OLMA
• Pieris Pharmaceuticals, Inc. PIRS
• Protara Therapeutics, Inc. TARA
• Sana Biotechnology, Inc. SANA
• Sonnet BioTherapeutics Holdings, Inc. SONN
• SQZ Biotechnologies Company SQZ
• Syros Pharmaceuticals, Inc. SYRS
• Vaccitech plc VACC (went public Friday)
• VectivBio Holding AG VECT
• Voyager Therapeutics, Inc. VYGR
• VYNE Therapeutics Inc. VYNE

Stocks In Focus

Stealth Biotherapeutics Reports Positive Phase 1 Data For Eamipretide In Retinal Disorder

Stealth BioTherapeutics Corp 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 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

Quidel Corporation QDEL announced a retail collaboration with Walgreens Boots Alliance, Inc. WBA to make Quidel's non-prescription QuickVue At-Home over-the-counter COVID-19 test available to consumers at 7,600 Walgreens locations across the U.S. and Puerto Rico. The shelf-stable packages, each containing two of the self-administered rapid antigen tests, can also be ordered online at Walgreens.com for store pick-up or same day delivery.

Moderna Announces Positive Phase 2 Data For Booster Dose of COVID-19 Vaccines, Mixed Q1

Moderna, Inc. MRNA announced initial data from its Phase 2 study showing that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and the South African and Brazilian variants.

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. 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. 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 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. 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

FDA's Arthritis Advisory Committee is scheduled to meet on Thursday to discuss ChemoCentryx, Inc.'s CCXI NDA for avacopan oral capsules, for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis. The meeting is scheduled between 10 a.m. and 4:15 p.m. The stock came under pressure Tuesday following not-so-encouraging review by FDA staffers.

Clinical Readouts

Palatin Technologies, Inc. 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 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

• Moderna, Inc. MRNA (before the market open)
• Intellia Therapeutics, Inc. NTLA (before the market open)
• Intercept Pharmaceuticals, Inc. ICPT (before the market open)
• Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
• Insmed Incorporated INSM (before the market open)
• Fulcrum Therapeutics, Inc. FULC (before the market open)
• Endo International plc ENDP (before the market open)
• Bio-Techne Corporation TECH (before the market open)
• Harvard Bioscience, Inc. HBIO (before the market open)
• Athenex, Inc. ATNX (before the market open)
• Zoetis Inc. ZTS (before the market open)
• Aldeyra Therapeutics, Inc. ALDX (before the market open)
• Syros Pharmaceuticals, Inc. SYRS (before the market open)
• Albireo Pharma, Inc. ALBO (before the market open)
• BioCryst Pharmaceuticals, Inc. BCRX (before the market open)
• Regeneron Pharmaceuticals, Inc. REGN (before the market open)
• Autolus Therapeutics plc AUTL (before the market open)
• BioDelivery Sciences International, Inc. BDSI (before the market open)
• Adaptimmune Therapeutics plc ADAP (before the market open)
• Axcella Health Inc. AXLA (before the market open)
• Antares Pharma, Inc. ATRS (before the market open)
• Agenus Inc. AGEN (before the market open)
• ADC Therapeutics SA ADCT (before the market open)
• Reata Pharmaceuticals, Inc. RETA (before the market open)
• Epizyme, Inc. EPZM (before the market open)
• Coherus BioSciences, Inc. CHRS (after the close)
• Dicerna Pharmaceuticals, Inc. DRNA (after the close)
• Chiasma, Inc. CHMA (after the close)
• Aurinia Pharmaceuticals Inc. AUPH (after the close)
• Athersys, Inc. ATHX (after the close)
• Acorda Therapeutics, Inc. ACOR (after the close)
• Acceleron Pharma Inc. XLRN (after the close)
• Axonics, Inc. AXNX (after the close)
• Puma Biotechnology, Inc. PBYI (after the close)
• Twist Bioscience Corporation TWST (after the close)
• T2 Biosystems, Inc. TTOO (after the close)
• ICU Medical, Inc. ICUI (after the close)
• Travere Therapeutics, Inc. TVTX (after the close)
• NovaBay Pharmaceuticals, Inc. NBY (after the close)
• Kura Oncology, Inc. KURA (after the close)
• Natera, Inc. NTRA (after the close)
• Zogenix ZGNX (after the close)
• Nektar Therapeutics NKTR (after the close)
• Eiger BioPharmaceuticals, Inc. EIGR (after the close)
• Vir Biotechnology, Inc. VIR (after the close)
• Iovance Biotherapeutics, Inc. IOVA (after the close)
• Evofem Biosciences (after the close)
• Caladrius Biosciences, Inc. CLBS (after the close)
• Quidel Corporation QDEL (after the close)
• Corcept Therapeutics Incorporated CORT (after the close)
• Insulet Corporation PODD (after the close)
• Fluidigm Corporation FLDM (after the close)
• Cardiovascular Systems, Inc. CSII (after the close)
• CytomX Therapeutics, Inc. CTMX (after the close)
• Cytokinetics, Incorporated CYTK (after the close)
• Dynavax Technologies Corporation DVAX (after the close)
• Collegium Pharmaceutical, Inc. COLL (after the close)
• Enanta Pharmaceuticals, Inc. ENTA (after the close)
• Fulgent Genetics, Inc. FLGT (after the close)
• Chembio Diagnostics, Inc. CEMI (after the close)
• Guardant Health, Inc. GH (after the close)
• Tricida, Inc. TCDA (after the close)
• Neovasc Inc. NVCN (after the close)
• Spero Therapeutics, Inc. SPRO (after the close)
• Misonix, Inc. MSON (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates