BPC October 25 update

10 Biotech Stock Regulatory Events to watch in November; Biotech week in review

Weekly watchlist

This week’s biotech watch list looks at regulatory events slated for November, which include events such as Advisory Committee and PDUFA dates. For those that are new to the sector, the PDUFA date refers to the deadline where the FDA issues its decision whether to approve the drug application or not.

Occasionally, prior to the PDUFA date the FDA will convene a panel of experts called an Advisory Committee, which will debate the pros and cons together with the company who submitted the drug application. While the FDA is not bound by the advice and overall vote of the committee, it generally sides with their decision.

Before we look at regulatory events slated for November, we review the week that was which started with many biotech stocks feeling the heat at ESMO (European Society for Medical Oncology) meeting. Looking ahead, the next major oncology conference is the Society for Immunotherapy of Cancer (SITC) Meeting held from November 7-11, while abstracts for December's American Society of Hematology (ASH) meeting will be released on November 1, 2018, 9:00 a.m EST.

Adaptimmune Therapeutics (Nasdaq: ADAP) presented initial data from the first two cohorts of its ongoing studies with its MAGE-A10 and MAGE-A4 SPEAR T-cells at ESMO. The data showed no response which caused shares to slide 30% to $7.55. 

Mirati Therapeutics, Inc. (NASDAQ: MRTX) shares closed Monday down 15% to $34.01 following the presentation of data from its Phase 2 trial of sitravatinib in combination with Opdivo in non-small cell lung cancer (NSCLC) patients. The data showed response rates below expectations, causing shares to fall 20%.

Merck (NYSE:MRK) announced preliminary data from a Phase 1 clinical trial evaluating MK-1454, an investigational STING (stimulator of interferon genes) agonist, as monotherapy in patients with advanced solid tumors or lymphomas. In the monotherapy arm, no complete or partial responses were observed (n=0/20). While there was not a major impact on its share price, the disappointing data saw shares of Aduro Biotech Inc. (NASDAQ:ADRO) slip 29% to $4.43. The company is also developing a STING agonist in patients with advanced solid tumors or lymphomas. Initial data from its Phase 1 trial of ADU-S100 are due to be presented at the Society for Immunotherapy of Cancer (SITC) meeting on November 9, 2018. 

Clementia Pharmaceuticals Inc. (Nasdaq: CMTA) shares closed Thursday up 40% to $14.50 following its announcement it plans to submit a New Drug Application (NDA) for palovarotene to the FDA in 2H 2019 based on completed Phase 2 trial data. 

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) shares slumped to close Friday down 69% to $0.40 following news that it has been unable to secure a buyer for the company, with concerns regarding the potential of bankruptcy if it is unable to get covenant relief for its term loan agreement.

Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX) announced Thursday that its Phase 2 trial of entinostat plus exemestane for breast cancer, did not achieve the first primary endpoint of improving progression-free survival (PFS). Shares closed Friday down 17% to $5.01.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) shares closed Friday down 18% to $48.62 following news its Phase 3 trial of UX007 in patients with glucose transporter type-1 deficiency syndrome (Glut1 DS) experiencing disabling paroxysmal movement disorders did not achieve both primary and secondary endpoints.


10 Biotech Stock FDA regulatory events to watch in November: Note that briefing documents for advisory committee meetings are released to the public TWO DAYS prior to the actual meeting.

Drug Stage Catalyst Market Cap

ACRX – AcelRx Pharmaceuticals Inc.
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure

Approved FDA Approval announced November 2, 2018.
$172.1 million

ALKS – Alkermes plc
ALKS 5461
Major depressive disorder

PDUFA PDUFA date of January 31, 2019. Advisory Committee Meeting November 1, 2018 voted 2-21 against recommending approval.
$5.1 billion

CHRS – Coherus BioSciences Inc.
CHS-1701
Pegfilgrastim biosimilar

Approved FDA approval announced November 2, 2018.
$661.9 million

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
Lambert-Easton Myasthenic Syndrome (LEMS)

Approved FDA approval announced November 28, 2018.
$240.4 million

HSGX – Histogenics Corporation
NeoCart
Cartilage defects in the knee

Phase 3 Phase 3 data released September 5, 2018. Primary endpoint not met. Update regarding possibility of filing BLA expected by end 2018 or early 2019.
$34 million

LOXO – Loxo Oncology Inc.
Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.

Approved FDA Approval announced November 26, 2018.
$4.3 billion

MNK – Mallinckrodt plc
MNK-812
Pain

CRL CRL issued December 12, 2018.
$1.6 billion

SAGE – Sage Therapeutics Inc.
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate

PDUFA priority review PDUFA date extended three months to March 19, 2018. Advisory Committee meeting November 2, 2018 voted 17-1 recommending approval.
$4.8 billion

TBPH – Theravance Biopharma Inc.
Revefenacin
COPD

Approved FDA Approval announced November 9, 2018.
$1.5 billion

TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain

CRL CRL issued November 2, 2018.
$47.8 million