The Daily Biotech Pulse: Merck Reports Positive Keytruda Readout, Moderna Slips Despite Q2 Beat, Bayer To Buy Vividion For Up To $2B, GlycoMimetics Gets New CEO

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. 4)

• Absci, CORP ABSI (IPOed July 22)
• Alkermes plc ALKS
• Alnylam Pharmaceuticals, Inc. ALNY
• Bio-Rad Laboratories, Inc. BIO
• Bristol-Myers Squibb Company BMY
• BeyondSpring Inc. BYSI (announced positive topline results for the registrational trial of plinabulin in combination with docetaxel for treating advanced lung cancer)
• BioNTech SE BNTX (moved on COVID-19 vaccine momentum)
• Cytek Biosciences, Inc. CTKB (IPOed July 23)
• DexCom, Inc. DXCM
• Edwards Lifesciences Corporation EW
• Eli Lilly and Company LLY
• Genmab A/S GMAB
• Horizon Therapeutics Public Limited Company HZNP(reacted to second-quarter results)
• Immuneering Corporation IMRX (IPOed Friday)
• Innoviva, Inc. INVA
• Impel NeuroPharma, Inc. IMPL
• Intuitive Surgical, Inc. ISRG
• Johnson & Johnson JNJ
• Laboratory Corporation of America Holdings LH
• Maravai LifeSciences Holdings, Inc. MRVI
• Moderna, Inc. MRNA
• Monte Rosa Therapeutics, Inc. GLUE
• Myriad Genetics, Inc. MYGN
• Novo Nordisk A/S NVO (reacted to half-year results)
• Nuvalent, Inc. NUVL (IPOed Thursday)
• Protagonist Therapeutics, Inc. PTGX
• Quest Diagnostics Incorporated DGX
• Repligen Corporation RGEN
• ResMed Inc. RMD
• Translate Bio, Inc. TBIO - extended the upward momentum seen Wednesday on its proposed sale to Sanofi SNY
• Zoetis Inc. ZTS (announced plans to buy Australia-based Jurox, a manufacturer of livestock and companion diagnostic products)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 4)

• Acurx Pharmaceuticals, Inc. ACXP
• Akero Therapeutics, Inc. AKRO
• Amryt Pharma plc AMYT
• Arena Pharmaceuticals, Inc. ARNA
• Aridis Pharmaceuticals, Inc. ARDS
• Avidity Biosciences, Inc. RNA
• Atai Life Sciences N.V. ATAI
• AVROBIO, Inc. AVRO
• Aytu Biopharma, Inc. AYTU
• Cabaletta Bio, Inc. CABA
• Cara Therapeutics, Inc. CARA
• Celyad Oncology SA CYAD
• Corvus Pharmaceuticals, Inc. CRVS
• Cytosorbents Corporation CTSO (reacted to second-quarter results)
• Deciphera Pharmaceuticals, Inc. DCPH
• Edgewise Therapeutics, Inc. EWTX
• Ensysce Biosciences, Inc. ENSC
• Evoke Pharma, Inc. EVOK
• EyeGate Pharmaceuticals, Inc. EYEG
• Flexion Therapeutics, Inc. FLXN
• Foghorn Therapeutics Inc. FHTX
• Harpoon Therapeutics, Inc. HARP
• Heron Therapeutics, Inc. HRTX
• Immunic, Inc. IMUX
• Immunocore Holdings plc IMCR
• Indaptus Therapeutics, Inc. Common Stock INDP
• InMed Pharmaceuticals Inc. INM
• Kala Pharmaceuticals, Inc. KALA
• Karyopharm Therapeutics Inc. KPTI
• Kinnate Biopharma Inc. KNTE
• Liminal BioSciences Inc. LMNL
• Lixte Biotechnology Holdings, Inc. LIXT
• Mersana Therapeutics, Inc. MRSN
• Minerva Neurosciences, Inc. NERV
• Moleculin Biotech, Inc. MBRX
• Nautilus Biotechnology, Inc. NAUT
• Neoleukin Therapeutics, Inc. NLTX
• Orphazyme A/S ORPH
• Otonomy, Inc. OTIC
• Outset Medical, Inc. OM
• Oyster Point Pharma, Inc. OYST
• Praxis Precision Medicines, Inc. PRAX
• Progenity, Inc. PROG
• Pulmatrix, Inc. PULM
• Puma Biotechnology, Inc. PBYI
• Rhythm Pharmaceuticals, Inc. RYTM
• Rockwell Medical, Inc. RMTI
• RxSight, Inc. RXST (IPOed Friday)
• Sigilon Therapeutics, Inc. SGTX
• Spruce Biosciences, Inc. SPRB
• Surface Oncology, Inc. SURF
• TFF Pharmaceuticals, Inc. TFFP
• TherapeuticsMD, Inc. TXMD (announced second-quarter results)
• Trevena, Inc. TRVN
• Xeris Pharmaceuticals, Inc. XERS
• Zymergen Inc. ZY (announced delay in commercial product delivery and termination of its CEO)

Stocks In Focus

Bayer To Buy US-based Immuno-Oncology Biopharma Vividion For Up To $2B

Germany's Bayer Aktiengesellschaft BAYRY announced the acquisition of Vividion Therapeutics, Inc., for $1.5 billion upfront and up to $500 million in milestone payments.

U.S.-based Vividion uses novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics.

Vividion's platform is able to produce a variety of small molecule therapies across indications, with initial focus on targets relevant to oncology and immunology. Its lead programs include multiple precision oncology targets. 

Merck Application For Keytruda In Adjuvant Skin Cancer Setting Accepted For Priority Review Following Positive Readout

Merck & Co., Inc. MRK said the Phase 3 KEYNOTE-716 trial investigating Keytruda met its primary endpoint of recurrence-free survival for the adjuvant treatment of patients with surgically resected high-risk stage II melanoma.

At an interim analysis, treatment with Keytruda as a single agent showed a statistically significant and clinically meaningful improvement in RFS compared with placebo as adjuvant therapy for these patients. No new safety signals were observed.

Based on the data, the FDA has accepted a new supplemental biologics license application for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection. The FDA granted the application priority review and assigned a PDUFA target action date of Dec. 4.

The stock was adding 0.23% to $75.65 in premarket trading.

Paratek Pharma's Antibiotic Included In CDC Guidelines For Treating Primary Bubonic, Pharyngeal Plague Infections

Paratek Pharmaceuticals, Inc. PRTK announced that its once-daily oral and intravenous antibiotic Nuzyra has recently been added to the Center for Disease Control and Prevention's updated report, "Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response."

Nuzyra was added as an alternative agent for the treatment, pre-exposure prophylaxis, and postexposure prophylaxis of primary bubonic and pharyngeal plague infections in adults 18 years of age and over.

The stock was adding 12.34% to $6.10 in premarket trading.

Glycomimetics Appoints Harout Semerjian As CEO

GlycoMimetics, Inc. GLYC said its board has appointed Harout Semerjian as chief executive officer effective Thursday to succeed retiring founding CEO Rachel King.

Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia, the company said. 

Related Link: The Week Ahead In Biotech (Aug. 1-7): Biopharma Earnings Pick Up Pace, Eton Awaits FDA Decision, Focus On Pending Clinical Readouts and IPOs

Adaptive Biotech Appoints Guardant Health Exec As Chief Commercial Officer

Adaptive Biotechnologies Corporation ADPT announced the appointment of Nitin Sood to the newly created position of chief commercial officer effective immediately.

The company said Sood brings more than 15 years of proven commercial experience at leading life sciences and diagnostics companies, most recently at Guardant Health GH.

The stock was rising 1.71% to $38 in premarket trading.

Kadmon's Rezurock Included In NCCN Guidelines As Systemic Agent For Graft-Versus-Host Disease

Kadmon Holdings, Inc. KDMN said the National Comprehensive Cancer Network added Rezurock tablets to its NCCN Clinical Practice Guidelines in Oncology for hematopoietic cell transplantation in the pre-transplant recipient evaluation and management of graft-versus-host disease.

The NCCN guidelines now include Rezurock with a Category 2A designation as a suggested systemic agent for steroid-refractory chronic GVHD.

Adamas To Sell Significant Assets Of US Compounding Business For Up To $15M

Adamas Pharmaceutical Corporation ADMP announced it has entered into a definitive agreement to sell a significant portion of the assets of its subsidiary, US Compounding Inc., related to USC's human compounding pharmaceutical business and customers, in exchange for total gross consideration estimated to be up to $15 million before transaction fees and expenses.

The consideration will be paid by the buyer to Adamas in monthly installments over the course of approximately 12 months based on a multiple of gross revenue generated by the assets during the measurement period.

Earnings

Acadia Pharmaceuticals Inc. ACAD said net sales of its Nuplazid increased from $110.1 million in the second quarter of 2020 to $115.2 million in the second quarter of 2021. The loss per share was flat at 27 cents per share. The revenues trailed consensus estimates.

The stock was slipping 7.13% to $19.55 in premarket trading.

Nevro Corp.'s NVRO second-quarter worldwide revenues jumped 81% to $102.3 million. The loss per share narrowed from $1.21 to 62 cents. The company guided third-quarter revenues to a range of $90 million to $93 million.

The company's second-quarter revenues trailed expectations and the third-quarter revenue guidance was also below estimates.

The stock was slumping 25.72% to $109.85 in premarket trading.

Moderna reported second-quarter earnings of $6.46 per share compared to a loss of 31 cents per share a year ago. Revenues came in at $4.4 billion. Both metrics were above consensus estimates. The company raised its expected delivery forecast for 2021 from $19.2 billion to $20 billion.

In premarket trading, Moderna shares were slipping 4.58% to $399.84.

Click here to access Benzinga's FDA Calendar.

On The Radar

Thursday Earnings

• Salarius Pharmaceuticals, Inc. SLRX (before the market open)
• OrthoPediatrics Corp. KIDS (before the market open)
• Mersana Therapeutics, Inc. MRSN (before the market open)
• Lumos Pharma, Inc. LUMO (before the market open)
• Karyopharm Therapeutics Inc. KPTI (before the market open)
• Galmed Pharmaceuticals Ltd. GLMD (before the market open)
• Jounce Therapeutics, Inc. JNCE (before the market open)
• Kala Pharmaceuticals, Inc. KALA (before the market open)
• Arena Pharmaceuticals, Inc. ARNA (before the market open)
• Antares Pharma, Inc. ATRS (before the market open)
• Arbutus Biopharma Corporation ABUS (before the market open)
• Aldeyra Therapeutics, Inc. ALDX (before the market open)
• Provention Bio, Inc. PRVB (before the market open)
• Autolus Therapeutics plc AUTL (before the market open)
• Wave Life Sciences Ltd. WVE (before the market open)
• Amarin Corporation plc AMRN (before the market open)
• Verona Pharma plc VRNA (before the market open)
• Chimerix, Inc. CMRX (before the market open)
• Concert Pharmaceuticals, Inc. CNCE (before the market open)
• Syros Pharmaceuticals, Inc. SYRS (before the market open)
• Stealth BioTherapeutics Corp MITO (before the market open)
• Strongbridge Biopharma plc SBBP (before the market open)
• Synthetic Biologics, Inc. SYN (after the close)
• CTI BioPharma Corp. CTIC (after the close)
• Y-mAbs Therapeutics, Inc. YMAB (after the close)
• Kura Oncology, Inc. KURA (after the close)
• Aligos Therapeutics, Inc. ALGS (after the close)
• Arcus Biosciences, Inc. RCUS (after the close)
• AVEO Pharmaceuticals, Inc. AVEO (after the close)
• Assertio Holdings, Inc. ASRT (after the close)
• Anika Therapeutics, Inc. ANIK (after the close)
• T2 Biosystems, Inc. TTOO (after the close)
• Caladrius Biosciences, Inc. CLBS (after the close)
• CytomX Therapeutics, Inc. CTMX (after the close)
• Collegium Pharmaceutical, Inc. COLL (after the close)
• Chembio Diagnostics, Inc. CEMI (after the close)
• Nabriva Therapeutics plc NBRV (after the close)
• Enanta Pharmaceuticals, Inc. ENTA (after the close)
• TransMedics Group, Inc. TMDX (after the close)
• iRhythm Technologies, Inc. IRTC (after the close)
• Sangamo Therapeutics, Inc. SGMO (after the close)
• Revance Therapeutics, Inc. RVNC (after the close)
• Spero Therapeutics, Inc. SPRO (after the close)
• Outset Medical, Inc. OM (after the close)
• Oncternal Therapeutics, Inc. ONCT (after the close)
• Natera, Inc. NTRA (after the close)
• Opiant Pharmaceuticals, Inc. OPNT (after the close)
• Novavax, Inc. NVAX (after the close)
• Mirum Pharmaceuticals, Inc. MIRM (after the close)

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