BPC May 08 update

Final week of biotech earnings; Selection of companies presenting at ASCO; Biotech week in Review

Weekly watchlist

Widely regarded as the major oncology conference of the year, ASCO 2020 will be held this year in a virtual format due to COVID-19. Abstract titles have been released for the meeting, scheduled to commence on May 29. Most abstracts will be released on May 13 at 5pm ET, with late-breaking abstracts set to be made available on May 28.

We note a selection of anticipated presentations, while also noting below key companies set to report during the last full week of first quarter earnings. First, let’s review the week that was with key price-moving events.

Moderna, Inc. (NASDAQ:MRNA) provided noted that it intends to initiate a Phase 3 trial of its COVID-19 vaccine, mRNA-1273, early this summer, compared with previous guidance of a start during this fall. A Phase 2 trial is scheduled to commence imminently. Shares closed the week up 24% to $59.25.

MacroGenics, Inc. (NASDAQ: MGNX) shares closed the week up 204% to $20.34 following an update in its first quarter earnings call of data to be presented at ASCO from its Phase 1 trial of MGD013 in solid tumor patients. The company noted that in a cohort of patients with advanced HER2-positive tumors treated with a combination of MGD013 and margetuximab, confirmed and unconfirmed objective responses over in excess of 40% were observed.

Tetraphase Pharmaceuticals, Inc. (NASDAQ: TTPH) shares closed the week up 53% to $2.02 following news that La Jolla Pharmaceutical Company (NASDAQ: LJPC) has proposed to acquire Tetraphase for $22m in cash plus an additional $12.5m potentially payable under Contingent Value Rights (CVRs).

Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) announced it will be acquired by Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) for $18 per share in cash. Shares closed the week up 154% to $17.90.

Stemline Therapeutics Inc., (NASDAQ:STML) announced it will also be acquired, by Menarini Group, a privately held Italian pharmaceutical company, for up to $677m. Stemline shareholders will be offered a total potential consideration of $12.50 per share, consisting of an upfront payment of $11.50 in cash and one non-tradeable CVR of an additional $1.00 in cash per share. Shares closed the week up 156% to $12.18.

TG Therapeutics, Inc. (NASDAQ: TGTX) shares closed the week up 67% $18.82 following its announcement that its Phase 3 UNITY-CLL trial evaluating the combination of umbralisib plus ublituximab compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL), met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) (p<.0001).

Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced that it met primary endpoints in its Phase 3 INNO2VATE trial, evaluating the efficacy and safety of vadadustat, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Shares closed the week up 50% to $11.98.


Selection of companies reporting 1Q earnings. Further companies listed on the BioPharmCatalyst Earnings Calendar for premium members:




Drug Stage Catalyst Market Cap

ALLO – Allogene Therapeutics Inc.
Non-Hodgkin lymphoma (NHL)

Phase 1 Phase 1 further data due 1H 2021.
$4.5 billion

AMGN – Amgen Inc.
AMG 510
Solid tumors

Phase 1 Phase 1 update at ASCO May 29, 2020. Objective response rate (ORR) was 12% (3/25) in 960 mg once-daily target dose cohort.
$132.1 billion

ARVN – Arvinas Inc.
Castration-resistant prostate cancer (CRPC)

Phase 1 Phase 1 update due December 2020.
$1 billion

AVEO – AVEO Pharmaceuticals Inc.
Third line treatment of patients with renal cell cancer

PDUFA PDUFA date March 31, 2021.
$149.5 million

AZN – AstraZeneca PLC
Tagrisso (ADAURA)
Non-small Cell Lung Carcinoma

PDUFA priority review PDUFA date under priority review (sNDA) 1Q 2021 - estimate February 20, 2020 based on 4-mth timeline from acceptance date.
$138.5 billion

CRVS – Corvus Pharmaceuticals Inc.
Solid tumors - cancer

Phase 1b Phase 1b/2 initial data from the RCC cohort at ASCO May 29, 2020. AdenoSig positive group -ORR of 17%. AdenoSig negative group - no partial responses.
$110.3 million

CTMX – CytomX Therapeutics Inc.
Solid tumors / diffuse large B-cell lymphoma (DLBCL)

Phase 2 Phase 2 initial data due late-2021.
$336.1 million

IMGN – ImmunoGen Inc.
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer

Phase 1/2 Phase 1b/2 data from platinum-sensitive triplet cohort at ESMO September 2020 noted overall response rate (ORR) of 83%, with a median duration of response (DOR) of 10.9 months and median progression free survival (PFS) of 12.8 months.
$1.1 billion

IOVA – Iovance Biotherapeutics Inc.
LN-144 - lifileucel
Refractory metastatic melanoma

BLA Filing BLA filing due 2021.
$6.1 billion

MGNX – MacroGenics Inc.
Tebotelimab (MGD013)
Solid tumors

Phase 1 Phase 1 data presented at SITC November 9-14, 2020.
$1.3 billion

MRK – Merck & Company Inc. (new)
Keytruda KN-177
Colorectal cancer (CRC)

Approved FDA Approval announced June 29, 2020.
$206.1 billion

MRSN – Mersana Therapeutics Inc.
Ovarian Cancer, Non Small Cell Lung Cancer

Phase 1 Phase 1 interim update September 17, 2020 noted 34% objective response rate and 79% disease control rate.
$1.6 billion

PFE – Pfizer Inc.
Bavencio (Avelumab) - JAVELIN Bladder 100
Bladder cancer

Approved FDA approval announced June 30, 2020.
$222.8 billion

RHHBY – Roche Holding AG ADR
Tiragolumab and atezolizumab - CITYSCAPE
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 data presented at ASCO May 29, 2020.
$285.5 billion

TRIL – Trillium Therapeutics Inc.
Refractory lymphoma or multiple myeloma

Phase 1b Phase 1 presentation at due at ASH December 5, 2020.
$1.6 billion