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 Aug. 3)
- Absci, CORP ABSI (IPOed July 22)
- Alkermes plc ALKS
- Amphastar Pharmaceuticals, Inc. AMPH
- Bio-Rad Laboratories, Inc. BIO
- Bristol-Myers Squibb Company BMY
- BioNTech SE BNTX
- Cytek Biosciences, Inc. CTKB (IPOed July 23)
- Eli Lilly and Company LLY (announced its second-quarter results)
- Genmab A/S GMAB
- Imago BioSciences, Inc. IMGO (IPOed July 16)
- Immuneering Corporation IMRX (IPOed Friday)
- Innoviva, Inc. INVA
- Intuitive Surgical, Inc. ISRG
- Johnson & Johnson JNJ
- Maravai LifeSciences Holdings, Inc. MRVI
- Moderna, Inc. MRNA (announced commencement of Phase 1 study of mRNA therapeutic candidate for autoimmune disorder)
- Monte Rosa Therapeutics, Inc. GLUE
- Myriad Genetics, Inc. MYGN
- Novo Nordisk A/S NVO
- Nuvalent, Inc. NUVL (IPOed Thursday)
- Pfizer Inc. PFE
- Quest Diagnostics Incorporated DGX
- Repligen Corporation RGEN
- ResMed Inc. RMD
- Translate Bio, Inc. TBIO (announced a deal to be bought by Sanofi SNY
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Aug. 3)
- Adicet Bio, Inc. ACET
- Akero Therapeutics, Inc. AKRO
- Alzamend Neuro, Inc. ALZN
- Arena Pharmaceuticals, Inc. ARNA
- Aridis Pharmaceuticals, Inc. ARDS
- Avidity Biosciences, Inc. RNA
- Aytu Biopharma, Inc. AYTU
- Cara Therapeutics, Inc. CARA
- Catalyst Pharmaceuticals, Inc. CPRX
- Centessa Pharmaceuticals Limited CNTA
- Cogent Biosciences, Inc. COGT
- Deciphera Pharmaceuticals, Inc. DCPH
- Ensysce Biosciences, Inc. ENSC
- Esperion Therapeutics, Inc. ESPR (reacted to its quarterly results)
- Epizyme, Inc. EPZM
- Foghorn Therapeutics Inc. FHTX
- Gemini Therapeutics, Inc. GMTX
- Global Blood Therapeutics, Inc. GBT
- Harpoon Therapeutics, Inc. HARP
- Hepion Pharmaceuticals, Inc. HEPA
- Heron Therapeutics, Inc. HRTX
- Immunovant, Inc. IMVT
- Innate Pharma S.A. IPHA
- Insmed Incorporated INSM
- Karyopharm Therapeutics Inc. KPTI
- Kiniksa Pharmaceuticals, Ltd. KNSA
- Kinnate Biopharma Inc. KNTE
- Liquidia Corporation LQDA
- Lyra Therapeutics, Inc. LYRA
- Mersana Therapeutics, Inc. MRSN
- Minerva Neurosciences, Inc. NERV
- Moleculin Biotech, Inc. MBRX
- Nautilus Biotechnology, Inc. NAUT
- Nektar Therapeutics NKTR
- Neoleukin Therapeutics, Inc. NLTX
- NuCana plc NCNA
- Orchard Therapeutics plc ORTX
- ORIC Pharmaceuticals, Inc. ORIC
- Orphazyme A/S ORPH
- Oyster Point Pharma, Inc. OYST
- Palisade Bio, Inc. PALI
- Panbela Therapeutics, Inc. PBLA
- Passage Bio, Inc. PASG
- Plus Therapeutics, Inc. PSTV
- Praxis Precision Medicines, Inc. PRAX
- Progenity, Inc. PROG
- Pulmatrix, Inc. PULM
- Puma Biotechnology, Inc. PBYI
- Reviva Pharmaceuticals Holdings, Inc. RVPH
- Rhythm Pharmaceuticals, Inc. RYTM (reacted to its second-quarter results)
- Sage Therapeutics, Inc. SAGE ( reacted to pipeline update and its second-quarter results)
- Spruce Biosciences, Inc. SPRB
- Teligent, Inc. TLGT
- Terns Pharmaceuticals, Inc. TERN
- TFF Pharmaceuticals, Inc. TFFP
- Trillium Therapeutics Inc. TRIL
- Vivos Therapeutics, Inc. VVOS
- Vor Biopharma Inc. VOR
- VYNE Therapeutics Inc. VYNE
- Xeris Pharmaceuticals, Inc. XERS
- ZIVO Bioscience, Inc. ZIVO
Stocks In Focus
Pfizer Announces Positive Phase 2b/3 Results For Autoimmune Disease That Causes Hair Loss
Pfizer announced positive top-line results from the Phase 2b/3 ALLEGRO trial evaluating oral once-daily ritlecitinib in patients with alopecia areata, an autoimmune disease driven by an immune attack on the hair follicles that causes hair loss on the scalp and can also affect the face and body.
Ritlecitinib 50 mg and 30 mg achieved the primary efficacy endpoint of the study, namely the proportion of patients with less than or equal to 20 percent scalp hair loss after six months of treatment versus placebo.
The stock was up 1.05% at $46.16 in premarket trading.
BioNTech Gains On Closure of Acquisition of Kite R&D Platform and Manufacturing Facility
BioNTech announced the closing of the acquisition of the solid tumor neoantigen T cell receptor R&D platform and clinical manufacturing facility's assets and leases in Gaithersburg from Kite. The transaction was announced on July 19.
The stock was up 2.74% to $361.45 in premarket trading.
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Zymergen Sinks On Delay In Commercial Product Delivery, Terminates CEO
Zymergen, Inc. ZY said it recently became aware of issues with its commercial product pipeline that will impact its delivery timeline and revenue projections. Accordingly, the company said it no longer expects product revenue in 2021, and expects product revenue to be immaterial in 2022.
The company noted that several key target customers encountered technical issues in implementing Hyaline into their manufacturing processes typical of new product and process development learnings.
The company also announced the stepping down of its Josh Hoffman as CEO and as a member of the board, effective immediately.
Zymergen preannounced June quarter revenues of $5 million to $6 million and operating expenses of $100 million to $105 million.
The stock was plunging 71.83% to $9.81 in premarket trading.
ObsEva Announces Publication of Positive Mid-stage Results For Nolasiban In Improving Pregnancy Following IVF
ObsEva SA OBSV Announced the publication of two peer-reviewed papers on nolasiban that is being developed for improving live birth rates in women undergoing embryo transfer following in-vitro fertilization.
The company noted that Phase 2 IMPLANT1 and Phase 3 IMPLANT 2 trials both demonstrated that administration of a single 900 mg dose of nolasiban administered before fresh single embryo transfer increased live birth rates compared to placebo. These results were not confirmed in a third trial, IMPLANT 4.
A patient-level combined analysis of the three studies showed a 5% absolute increase in ongoing pregnancy rate, with an odds ratio for nolasiban versus placebo of 1.25 that was statistically significant. The study also showed that the 900mg dose was well tolerated.
The stock was up 5.60% at $2.64 in premarket trading.
NRx Partners With Mannkind to Develop Zyesami Inhaler For Inflammatory Conditions
NRx Pharmaceuticals NRXP announced it has signed an agreement with MannKind Corporation MNKD to develop a dry powder formulation of Zyesami, a synthetic form of human vasoactive intestinal peptide, produced by the body to help protect cells against inflammatory conditions.
Development will be based on MannKind's proven Technosphere platform, that is the basis of the Food and Drug Administration (FDA)-approved Afrezza inhaled insulin product.
Mannkind was adding 6.52% to $4.25 in premarket trading Tuesday, while NRx was rising 5.93% to $16.97.
Cerus Corporation's CERS second-quarter revenues climbed 41% to $37.8 million and the loss per share was flat at 9 cents. The revenues exceeded estimated, while the loss was in line.
The stock was up 14.04% at $5.85 in after-hours trading.
Global Blood Therapeutics, Inc. GBT said its second-quarter revenues increased from $31.5 million in 2020 to $47.56 million in 2021. The company's net loss per share widened from 86 cents per share to $1.12 per share. The results exceeded estimates.
In premarket trading, the stock was up 16.03% to $31.20.
Aquestive Therapeutics, Inc. AQST said its revenues fell from $21.7 million in the second quarter of 2020 to $15.3 million in the second quarter of 2021. The loss per share widened from 7 cents to 33 cents.
The results exceeded estimates.
The stock was seen rising 13.85% to $ 3.7 in premarket trading.
OraSure Technologies, Inc.'s OSUR second-quarter revenues climbed 97% to $57.6 million. The loss per share narrowed from 16 cents to 2 cents. The company guided second-quarter revenues to $45 million to $50 million. The results and the guidance trailed expectations.
The stock was retreating 8.22% to $11.39 in premarket trading.
Invitae Corporation NVTA reported second-quarter revenues of $116.3 million, up 152% year-over-year. The net loss per share narrowed from $1.29 to 64 cents.
The stock was advancing 12.07% to $31.94 in premarket trading.
On The Radar
TherapeuticsMD, Inc. TXMD (before the market open)
Intellia Therapeutics, Inc. NTLA (before the market open)
Surmodics, Inc. SRDX (before the market open)
Vericel Corporation VCEL (before the market open)
UroGen Pharma Ltd. URGN (before the market open)
Horizon Therapeutics Public Limited Company HZNP (before the market open)
IVERIC bio, Inc. ISEE (before the market open) (before the market open)
Flexion Therapeutics, Inc. FLXN (after the close)
Aerie Pharmaceuticals, Inc. AERI (after the close)
AxoGen, Inc. AXGN (after the close)
INmune Bio, Inc. INMB (after the close)
Bionano Genomics, Inc. BNGO (after the close)
DermTech, Inc. DMTK (after the close)
Fate Therapeutics, Inc. FATE (after the close)
G1 Therapeutics, Inc. GTHX (after the close)
Otonomy, Inc. OTIC (after the close)
Xencor, Inc. XNCR (after the close)
Celyad Oncology SA CYAD (after the close)
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