BPC December 21 update

Final biotech week in review for 2018

Weekly watchlist

The next BioPharmCatalyst weekly edition will be sent on January 5 with the newsletter taking a one-week break during the holiday season. The daily edition will continue to be published next week.

Readers following events on the BioPharmCatalyst FDA Calendar will have noticed a number of companies yet to release data slated for this month. While no doubt a number will push out press releases this coming week, do not be surprised if most of the events end up being pushed out to 1Q 2019.

The final full trading week of 2018 brought a flood of biotech news flow, akin to what is usually reserved for earnings season. We highlight key events from the week that was, much of it to the downside, followed by a few events likely to be released next week. There are just a few, however, in what should be a quiet week of news flow ahead.

FibroGen, Inc. (NASDAQ:FGEN) announced that it received approval in China for roxadustat, for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis. The company also announced that three Phase 3 trials of roxadustat, met all primary efficacy endpoints.

Aduro Biotech, Inc. (NASDAQ: ADRO) shares closed Wednesday up 20% to $2.96 following news of a partnership with Eli Lilly and Company (NYSE: LLY) for its cGAS-STING Pathway Inhibitor program for immunotherapies for autoimmune and other inflammatory diseases. Aduro receives $12m upfront and will be eligible for milestones up to approximately $620m per product.

Agenus Inc. (NASDAQ: AGEN) shares closed Thursday up 23% to $2.48 following its announcement of a partnership deal with Gilead Sciences, Inc. (NASDAQ: GILD) for the development of up to five immuno-oncology therapies. Agenus will receive $150m upon closing, which includes a $120m upfront cash and a $30m equity investment.  The agreement also includes approximately $1.7b in milestone payments. 

Surface Oncology (Nasdaq: SURF) announced that it will not be opening expansion cohorts in its Phase 1 trial of SRF231 following news that two hematologic dose-limiting toxicities (DLTs) were seen at a lower dose than anticipated in its Phase 1 trial. Shares closed Wednesday down 48% to $3.89.

Dova Pharmaceuticals, Inc. (NASDAQ: DOVA) announced Monday that Alex Sapir is no longer President and Chief Executive Officer of the company. Shares closed the week down 54% to $6.80.

Sophiris Bio Inc. (NASDAQ: SPHS) shares closed the week down 59% to $0.85 following news that six-month biopsy results following the second administration of topsalysin in its Phase 2b for prostate cancer, showed no additional clinical benefit. 

Histogenics Corporation (Nasdaq: HSGX) shares plunged Friday, closing the after hours session down 84% to $0.08 on news that it will terminate development of NeoCart following an update from the FDA that an additional clinical trial would need to be completed before it would accept a submission of a Biologics License Application (BLA).

G1 Therapeutics, Inc. (Nasdaq: GTHX) shares closed Thursday down 43% to $16.51 following data from its Phase 2 trial evaluating trilaciclib in combination with topotecan as a treatment for 2nd/3rd line small cell lung cancer. The company noted an objective response rate (ORR) of only 13% compared with 23% for placebo.

DBV Technologies (Nasdaq: DBVT) shares slumped Thursday, closing down 59% to $5.76 on news it has withdrawn its Biologics License Application (BLA) for Viaskin Peanut for the treatment of peanut allergy.

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) shares closed Thursday down 39% to $6.39 following news that it has been unable to secure Breakthrough Therapy Designation (BTD) from the FDA for poziotinib for the treatment of non-small cell lung cancer (NSCLC). BTD is designed to expedite the review of drugs to treat serious or life threatening conditions. 

ADMA Biologics, Inc. (NASDAQ: ADMA) announced that the FDA issued a Complete Response Letter (CRL) for the drug substance Prior Approval Supplement (PAS) submission for Bivigam. Shares closed Thursday down 46% to $2.29.

Drug Stage Catalyst Market Cap

CFRX – ContraFect Corporation
CF-301
Serious infections caused byStaph aureus including MRSA

Phase 2 Phase 2 trial noted clinically meaningful data but not statistically significant. Phase 3 trial planned.
$37.5 million

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone
Refractory status epilepticus (RSE)

Phase 2 Data due by the end of 3Q 2019.
$215.5 million

PTLA – Portola Pharmaceuticals Inc.
Andexxa
Factor Xa inhibitor reversal agent

Approved Prior Approval Supplement (PAS) FDA Approval announced December 31, 2018.
$1.9 billion

SESN – Sesen Bio Inc.
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

BLA Filing Rolling BLA filing to commence 4Q 2019.
$119.5 million