BPC August 06 update

Denali DNLI rallies on selection of Parkinson’s candidate +36%; BioLineRx BLRX pancreatic readout delay -19%

Price and Volume Movers

GlaxoSmithKline plc (LSE/NYSE: GSK) announced late-Wednesday that the FDA approved Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies. It becomes the first anti-BCMA (B-cell maturation antigen) therapy approved.

Denali Therapeutics Inc. (NASDAQ: DNLI) announced that it has selected DNL151 to progress into late stage studies in Parkinson’s disease patients with a kinase activating mutation in LRRK2 and in sporadic Parkinson’s disease patients. Through a collaboration with Biogen (NASDAQ:BIIB) it will receive $560m upfront and a $465m equity investment. Patient enrollment is expected to commence in 2021. Shares closed up 36% to $31.66.

Editas Medicine, Inc. (Nasdaq: EDIT) announced that Abbvie (ABBV) has returned rights for its ocular medicines, including EDIT-101 for the treatment of Leber congenital amaurosis 10. Shares, which had rallied 13% during regular trading hours, are currently trading down 10% to $33.00 after hours.

Aditxt Therapeutics, Inc. (NASDAQ:ADTX) shares closed up 93% to $7.60 following its announcement that it has introduced AditxtScore for COVID-19 to be used in detecting antibodies against SARS-CoV-2 antigens. Aditxt plans to file for an Emergency Use Authorization (EUA) followed by a 510(K) application with the FDA this quarter. It anticipates beginning pilot programs in 4Q, 2020, with the goal of making AditxtScore commercially available starting in Q1, 2021.

Roche (OTCQX: RHHBY) announced that its Phase 3 IMpassion131 study, evaluating Tecentriq (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival (PFS) for the first-line treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population.

BioLineRx Ltd (NASDAQ:BLRX) shares closed down 19% to $1.91 following the release of second quarter earnings. In its report the company noted that data from its Phase 2 Combat trial of BL-8040 and Keytruda in patients with pancreatic cancer, will be released during the second half of the year, a delay on previous guidance of a mid-2020 readout.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

CohBar, Inc. (CWBR): $2.08; +24%.

Marinus Pharmaceuticals, Inc. (MRNS): $2.09; +18%.

Beam Therapeutics Inc. (BEAM): $24.52; +15%.

Adial Pharmaceuticals, Inc. (ADIL): $1.92; +15%.

ORIC Pharmaceuticals, Inc. (ORIC): $25.38; +14%.

DECLINERS:

Biofrontera AG (BFRA): $16.51; -38%.

TherapeuticsMD, Inc. (TXMD): $1.61; -21%.

ADMA Biologics, Inc. (ADMA): $2.86; -20%.

Alterity Therapeutics Limited (ATHE): $2.40; -18%.

Menlo Therapeutics Inc. (MNLO): $1.59; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGEN – Agenus Inc.
Balstilimab
Cervical cancer

BLA Filing Rolling BLA filing announced September 18, 2020.
$950.2 million

ALBO – Albireo Pharma Inc.
Odevixibat (A4250) - PEDFIC- 1
Progressive familial intrahepatic cholestasis (PFIC)

Phase 3 Phase 3 top-line data met primary endpoints - September 8, 2020.
$738.7 million

BLRX – BioLineRx Ltd.
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer

Phase 2 Phase 2 PFS and OS data due 2H 2020.
$34.6 million

CRBP – Corbus Pharmaceuticals Holdings Inc.
Resunab - RESOLVE-1
Systemic Sclerosis

Phase 3 Phase 3 top-line data did not meet endpoints - September 8, 2020.
$155.3 million

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)

Phase 3 Phase 3 trial met primary endpoint - September 14, 2020.
$422.8 million

NVO – Novo Nordisk A/S
Semaglutide (SUSTAIN FORTE)
Type 2 Diabetes

Phase 3 Phase 3 data due 4Q 2020.
$161.7 billion

PHAT – Phathom Pharmaceuticals Inc.
Vonoprazan PHALCON-EE
Erosive esophagitis / Gastroesophageal reflux disease (GERD)

Phase 3 Phase 3 top-line data due 2021.
$971.8 million

RHHBY – Roche Holding Ltd ADR (Sponsored)
Tecentriq and paclitaxel - Mpassion131
Triple-negative breast cancer (TNBC)

Phase 3 Phase 3 trial did not meet primary endpoint - October 6, 2020.
$320.3 billion

SELB – Selecta Biosciences Inc.
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout

Phase 2 Phase 2 top-line data due 3Q 2020.
$278.6 million

SGEN – Seattle Genetics Inc.
GSK’916 - belantamab mafodotin (BCMA)
Multiple myeloma

Approved FDA approval granted August 5, 2020.
$31.5 billion

SLGL – Sol-Gel Technologies Ltd.
VERED (Epsolay)
Papulopustular rosacea

PDUFA PDUFA date April 26, 2021.
$173.2 million

SRRA – Sierra Oncology Inc.
Momelotinib - MOMENTUM
Myelofibrosis

Phase 3 Phase 3 top-line data due 1H 2022.
$118.5 million

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-102 SL
Alcohol Use Disorder

Phase 2 Phase 2 trial planned. IND acceptance announced August 6, 2020.
$120.8 million

YMAB – Y-mAbs Therapeutics Inc.
Omburtamab
CNS/Leptomeningeal Metastases from Neuroblastoma

BLA Filing Rolling BLA filing has been completed - August 6, 2020.
$1.7 billion