The Daily Biotech Pulse: Urovant In M&A Deal, Sanofi's Binary Event, Conference Presentations

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 Nov. 12)

• ALX Oncology Holdings Inc ALXO
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• Celldex Therapeutics, Inc. CLDX
• Denali Therapeutics Inc DNLI
• Eidos Therapeutics Inc EIDX
• Fate Therapeutics Inc FATE
• Five Prime Therapeutics Inc FPRX (announced preclinical data supporting evaluation of FPA157 as a novel immunomodulator with the potential to remove Treg-mediated immune suppression in solid tumors)
• Generation Bio Co GBIO
• Guardant Health Inc GH
• Halozyme Therapeutics, Inc. HALO
• Inspire Medical Systems Inc INSP
• Insulet Corporation PODD
• Kodiak Sciences Inc KOD (announced presentation of clinical study data on its investigational therapy KSI-301 in retinal disorders)
• Kura Oncology Inc KURA
• MannKind Corporation MNKD
• Myokardia Inc MYOK
• Ocular Therapeutix Inc OCUL
• Oncorus Inc ONCR
• OncoSec Medical Inc ONCS
• Pacific Biosciences of California Inc PACB
• Repligen Corporation RGEN
• Shockwave Medical Inc SWAV
• Spero Therapeutics Inc SPRO
• Tcr2 Therapeutics Inc TCRR (announced its third-quarter results)
• Twist Bioscience Corp TWST
• Ultragenyx Pharmaceutical Inc RARE
• Veracyte Inc VCYT

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Nov. 12)

• Applied Therapeutics Inc APLT (announced its third-quarter results)
• Magenta Therapeutics Inc MGTA
• Neovasc Inc NVCN

Stocks In Focus

Urovant Majority Shareholder Buys Remaining Stake It Does Not Already Own In The Biopharma For $16.25/Share

Urovant Sciences Ltd UROV said it has entered into a definitive agreement under which Sumitovant Biopharma will acquire Urovant Sciences for $16.25 per share or approximately $584 million in total equity value on a fully diluted basis in an all-cash merger.

The per-share price represented a 96% premium over Urovant's closing share price of $8.28 on Nov. 12. During the merger, all Urovant stock, other than those held by Sumitovant, will be canceled and converted into the right to receive $16.25 per share.

Sumitovant already owns 72% equity stake in the company.

The transaction is expected to close in the first quarter of 2021, subject to approval by the minority shareholders.

Urovant shares jumped 90.82% to $15.80 in after-hours trading.

Cyclerion Rallies On Insider Buying

Cyclerion Therapeutics Inc CYCN revealed in a filing its Chief Innovation Officer Andreas Busch bought 125,000 shares in the company at $2.53 per share. Following the transaction, Busch beneficially owns 254,704 shares in the company.

The stock rose 7.66% to $2.67 in after-hours trading.

Karyopharm Announces Publication of Positive Xpovio Data In Multiple Myeloma Study

Karyopharm Therapeutics Inc KPTI announced publication in the Lancet results of the Phase 3 study evaluating Xpovio in patients with relapsed or refractory multiple myeloma.

The BOSTON study evaluated once weekly Xpovio, in combination with once weekly Velcade marketed by Takeda Pharmaceutical Co Ltd TAK and low-dose dexamethasone against standard twice weekly Velcade in adult patients with multiple myeloma who had received one to three prior lines of therapy.

The combo was found to reduce the risk of disease progression or death by 30% and induced a higher rate of overall and deep responses compared to patients receiving a standard twice-weekly Velcade and low-dose dexamethasone regimen.

In after-hours session, the stock was up 5.34% to $15.78.

Agios Gets Orphan Drug Designation For Drug to Treat Sickle Cell Disease

Agios Pharmaceuticals Inc AGIO said the FDA granted orphan drug designation to its first-in-class pyruvate kinase R activator mitapivat for the treatment of patients with sickle cell disease.

Innate Pharma Announces Prime Designation Award By European Drug Regulator

Innate Pharma SA IPHA said the European Medicines Agency has granted Prime designation to lacutamab, its proprietary first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, for the treatment of patients with relapsed or refractory Sézary syndrome, who have received at least two prior systemic therapies.

Earnings

Navidea Biopharmaceuticals Inc NAVB said its third-quarter revenues increased from $237,000 in 2019 to $268,000 in 2020. The loss per share narrowed from 17 cents to 13 cents. Analysts had estimated a loss of 9 cents per share.

Updating on its clinical programs, the company said the Phase 2b trial in rheumatoid arthritis is proceeding well, and preparation of package to discuss with the FDA plan for upcoming Phase 3 study is nearing completion.

The stock skyrocketed 39.73% to $3.13 in after-hours trading.

Biocept Inc's BIOC third-quarter revenues jumped from $1.5 million in 2019 to $6.6 million in 2020, with the increase attributable to RT-PCR COVID-19 testing. The net loss per share narrowed significantly from $2.47 to 43 cents. Analysts had estimated a loss of 47 cents per share.

The stock plunged 16.40% to $5.15 in after-hours trading.

Opiant Pharmaceuticals Inc OPNT reported third-quarter revenues of $9.1 million, lower than $20.6 million in the year-ago period. The company's net loss per share narrowed from $1.97 to 15 cents. Analysts had modeled a loss of 21 cents per share.

In after-hours trading, the stock jumped 10.27% to $8.05.

On The Radar

PDUFA Dates

Sanofi SA SNY awaits FDA nod on its BLA for sutimlimab as a treatment option for hemolysis in adult patients with cold agglutinin disease.

Clinical Readouts/Presentations

American Academy of Ophthalmology Virtual Meeting Presentations

MeiraGTx Holdings PLC MGTX: 12-month results from the Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy for the treatment of X-linked retinitis pigmentosa (5:55 pm)
Adverum Biotechnologies Inc ADVM: additional clinical data for Cohorts 1-4 in the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal injection gene therapy in wet age-related macular degeneration (2:15 pm)

ProQR Therapeutics NV PRQR: Phase 1b/2 trial results of intravitreal sepofarsen RNA therapy in Leber congenital amaurosis 10

NGM Biopharmaceuticals Inc NGM: detailed Phase 1 safety, tolerability and pharmacokinetics findings from single and multiple intravitreal injections of NGM621 in patients with geographic atrophy (10 am)

Regenxbio Inc RGNX: a poster presentation on update data on the subretinal RGX-314 gene therapy Phase 1/2a study for the treatment of neovascular AMD and data from preclinical studies of suprachoroidal delivery of RGX-314 (3:36 pm)

American Heart Association, or AHA, Scientific Sessions Presentations

Cytokinetics, Inc. CYTK and Amgen, Inc. AMGN: primary results from the GALACTIC-HFhe Phase 3 event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil in acute heart failure

American Association for the Study of Liver Diseases Liver Meeting Presentations

NGM Biopharmaceuticals: comprehensive data from its 24-week Phase 2 study (Cohort 4) of aldafermin in patients with non-alcoholic steatohepatitis

Metacrine Inc MTCR: new Phase 1b data on lead clinical candidate, MET409 for the treatment of non-alcoholic steatohepatitis

Madrigal Pharmaceuticals Inc MDGL: early data from the Phase 3 MAESTRO study of resmetirom in NASH and data from the MAESTRO-NAFLD-1 open label study (4:30-5 pm)

89bio Inc ETNB: Phase 1b/2a multiple ascending dose study of BIO89-100 in NASH

CymaBay Therapeutics Inc CBAY: data from a Phase 2 study of seladelpar in NASH

DURECT Corporation DRRX: additional safety and efficacy signals from a Phase 1b study of 4-Week Oral DUR-928 in NASH subjects

Can Fite Biopharma ADR Representing 30 Ord Shs CANF: data from the Phase 2, dose-finding study of the efficacy and safety Of namodenoson in treating NAFLD and NASH

Eiger Biopharmaceuticals Inc EIGR: a late-breaker oral presentation of end-of-study results from the LIFT HDV Phase 2 study of peginterferon lambda, lonafarnib, and ritonavir for 24 Weeks

Earnings

Meridian Bioscience, Inc. VIVO (before the market open)
Bio-Path Holdings Inc BPTH (before the market open)
AC Immune SA ACIU (before the market open)
Checkmate Pharmaceuticals Inc CMPI (before the market open)
Prevail Therapeutics Inc PRVL (before the market open)
Milestone Pharmaceuticals Inc MIST (before the market open)