The Daily Biotech Pulse: Merck Reports Positive Keytruda Data In Breast Cancer, Curis, Evoke Slump On Earnings, Qiagen's Rapid COVID-19 Antibody Test OK'ed For Emergency Use - iShares Biotechnology ETF (NASDAQ:IBB)

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 12)

Alexion Pharmaceuticals, Inc. ALXN
Curis, Inc. CRIS
HOOKIPA Pharma Inc. HOOK (announced first-quarter results)
Jazz Pharmaceuticals plc JAZZ
Novo Nordisk A/S NVO
Vaccitech plc VACC

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 12)

4D Molecular Therapeutics, Inc. FDMT
Akoya Biosciences, Inc. AKYA
Bellerophon Therapeutics, Inc. BLPH
Bolt Biotherapeutics, Inc. BOLT
Co-Diagnostics, Inc. CODX
Concert Pharmaceuticals, Inc. CNCE
Connect Biopharma Holdings Limited CNTB
Dyadic International, Inc. DYAI
Eloxx Pharmaceuticals, Inc. ELOX
Finch Therapeutics Group, Inc. FNCH
Galecto, Inc. GLTO
Gemini Therapeutics, Inc. GMTX
InflaRx N.V. IFRX (announced first-quarter results and a midstage readout for its investigational therapy for inflammation of blood vessels)
Instil Bio, Inc. TIL
Kiromic BioPharma, Inc. KRBP
Larimar Therapeutics, Inc. LRMR
LogicBio Therapeutics, Inc. LOGC
Longeveron Inc. LGVN
NuCana plc NCNA
Nymox Pharmaceutical Corporation NYMX
Odonate Therapeutics, Inc. ODT
Opthea Limited OPT
Orgenesis Inc. ORGS
Orphazyme A/S ORPH
PMV Pharmaceuticals, Inc. PMVP
PolyPid Ltd. PYPD (announced first-quarter results)
Praxis Precision Medicines, Inc. PRAX (reacted to a common stock offering)
Reneo Pharmaceuticals, Inc. RPHM
Scopus BioPharma Inc. SCPS
Sensei Biotherapeutics, Inc. SNSE
Soligenix, Inc. SNGX
Talaris Therapeutics, Inc. TALS
Talis Biomedical Corporation TLIS (announced first-quarter results)
VectivBio Holding AG VECT
Vallon Pharmaceuticals, Inc. VLON
Vor Biopharma Inc. VOR
Zealand Pharma A/S ZEAL (announced first-quarter results)

Stocks In Focus

Novo Nordisk's Diabetes Drug Found To Improve Quality Of Life In People With Obesity In Late-Stage Study

Novo Nordisk announced new results from the STEP Phase 3a clinical trial program that demonstrate potential benefits beyond weight loss for people with obesity being treated with semaglutide 2.4 mg.

Following the 68-week treatment period with once-weekly semaglutide, more than half of participants had improved quality of life scores, indicating better physical function and improved psychological wellbeing.

Celyad's Cell Therapy Candidate Shows Promise In Early Stage Blood Cancer Study

Celyad Oncology SA CYAD said Phase 1 data from the IMMUNICY-1 study of CYAD-211, a non-gene edited allogenic CAR T candidate, showed initial clinical activity, with one confirmed partial response in a low dose, in treating relapsed/refractory multiple myeloma.

There were no Grade 3 or greater treatment-related adverse events nor evidence of Graft-versus-Host disease reported from the completed first dose level.

The company said an abstract highlighting the data has been accepted for e-poster presentation at the upcoming European Hematology Association Virtual Congress 2021.

The stock was trading 19.21% higher premarket Thursday at $6.33.

4D Molecular Presents Positive Data From Animal Study Of Gene Therapy Candidate In Retinal Disorders

4D Molecular announced a presentation at the ASGCT Meeting of new preclinical data from non-human primate studies of 4D-150, a dual transgene, intravitreal gene therapy inhibiting four distinct VEGF family members for the treatment of wet age-related macular degeneration and diabetic macular edema.

The study demonstrated significant efficacy in the laser-induced choroidal neovascularization model, including complete suppression of CNV lesions at the lowest dose, the company said. High anti-VEGF levels within the NHP eye were observed, with no evidence of uveitis or retinal abnormalities, according to 4D Molecular.

Merck's Keytruda Found Effective, Safe In Neoadjuvant/Adjuvant Setting In Breast Cancer

Merck MRK announced positive results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial investigating Keytruda in combination with chemotherapy as pre-operative treatment, and then continuing as a single agent treatment after surgery.

The KEYNOTE-522 trial met its dual primary endpoint of event-free survival for the treatment of patients with high-risk, early stage triple-negative breast cancer. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies and no new safety signals were identified.

AzurRx's MS1819 Combo Therapy Aces Midstage Trial In Cystic Fibrosis Patients With Pancreatic Insufficiency

AzurRx BioPharma, Inc. AZRX announced positive interim data from the first 18 out of 20 patients in its Phase 2 trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy, for the treatment of severe exocrine pancreatic insufficiency in patients with cystic fibrosis.

The shares were adding 8.98% to 79.51 cents in premarket trading Thursday.

Qiagen Gets FDA Emergency Use Authorization For Portable Digital Antibody COVID-19 Test

QIAGEN N.V. QGEN said it has received emergency use authorization from the FDA for the fast, easy-to-use QIAreach anti-SARS-CoV-2 Total Test.

The authorization allows health care professionals gain access to portable rapid testing device that can monitor immune status in relation to COVID-19. The eHub digital device, according to the company, can handle eight tests at once, all working independently of each other, and can process up to 32 samples per hour. It can eventually be used simultaneously with the antigen test

Earnings

Curis reported first-quarter revenues of $2.19 million, down from $2.71 million in the year-ago period. The net loss narrowed from 28 cents to 11 cents.

The company also announced the release of abstract accepted for presentation at the EHA meeting, with interim data from the Phase 1/2 study of CA-4948 in patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome consistent with previously announced findings, including marrow blast reductions observed at all tested doses in eight of nine evaluable patients.

The stock plunged 13.95% to $45 in after-hours trading.

Profound Medical Corp PROF reported a decline in its first-quarter revenues from $1.16 million in 2020 to $711,000 in 2021. The loss per share widened from 21 cents

The stock slipped 11.7% to $16.70 in after-hours trading.

Evoke Pharma, Inc. EVOK reported net sales of about $90,000 and the net loss was $2.6 million, or 8 cents per share, compared to a net loss of approximately $1.8 million, or 7 cents per share for the first quarter of 2020. Analysts expected a smaller loss of 6 cents per share.

In after-hours trading, the stock plunged 21.71% to $1.19.

On The Radar

Clinical Readouts

Fate Therapeutics, Inc. FATE is scheduled to release interim Phase 1 data from its FT516 and FT538 programs at an investor event scheduled for Thursday. Both are iPSC-derived NK cell therapeutic candidates being evaluated for the treatment of relapsed/refractory acute myeloid leukemia.

Sio Gene Therapies, Inc. SIOX will present at the American Society of Gene and Cell Therapy meeting with preliminary results from the Phase 1/2 trial of AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. The company will also present efficacy, safety, and tolerability data six months post-administration from the second cohort in open-label dose evaluation study SUNRISE-PD of AXO-Lenti-PD gene therapy for Parkinson's disease.

Earnings

Galmed Pharmaceuticals Ltd. GLMD (before the market open)
Synlogic, Inc. SYBX (before the market open)
Wave Life Sciences Ltd. WVE (before the market open)
UroGen Pharma Ltd. URGN (before the market open)
Selecta Biosciences, Inc. SELB (before the market open)
PDS Biotechnology Corporation PDSB (before the market open)
Haemonetics Corporation HAE (before the market open)
Osmotica Pharmaceuticals plc OSMT (after the close)
ImmuCell Corporation ICCC (after the close)
Achieve Life Sciences, Inc. ACHV (after the close)
Daré Bioscience, Inc. DARE (after the close)
BioLife Solutions, Inc. BLFS (after the close)
Atea Pharmaceuticals, Inc. AVIR (after the close)
Anavex Life Sciences Corp. AVXL (after the close)
AbCellera Biologics Inc. ABCL (after the close)
aTyr Pharma, Inc. LIFE (after the close)
Aptinyx Inc. APTX (after the close)
Brickell Biotech, Inc. BBI (after the close)
Bionano Genomics, Inc. BNGO (after the close)
Co-Diagnostics, Inc. CODX (after the close)
Capricor Therapeutics, Inc. CAPR (after the close)
Dyadic International, Inc. DYAI (after the close)
DermTech, Inc. DMTK (after the close)
Lineage Cell Therapeutics, Inc. LCTX (after the close)
HTG Molecular Diagnostics, Inc. HTGM (after the close)
Eledon Pharmaceuticals, Inc. ELDN (after the close)
Eton Pharmaceuticals, Inc. ETON (after the close)
ThermoGenesis Holdings, Inc. THMO (after the close)
ProPhase Labs, Inc. PRPH (after the close)
Spectrum Pharmaceuticals, Inc. SPPI (after the close)
TFF Pharmaceuticals, Inc. TFFP (after the close)
Regulus Therapeutics Inc. RGLS (after the close)
Infinity Pharmaceuticals, Inc. INFI (after the close)
Marinus Pharmaceuticals, Inc. MRNS (after the close)
PolarityTE, Inc. PTE (after the close)

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